R3 XLPE INSERT

Report

• Report Number: 1020279-2025-00946
• Event Type: Injury
• Date Received: May 25, 2025
• Report Date: October 27, 2025
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: JDI
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: UK
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025) SUMMARY OF ADVERSE EVENTS: IT WAS REPORTED THAT, IN THE NATIONAL JOINT REGISTRY (NJR) FROM THE UNITED KINGDOM, A TOTAL OF SIXTY-FIVE THOUSAND THREE HUNDRED AND TWENTY-NINE (65,329) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 24-APR-2008 AND 26-FEB-2025, USING AN R3 XLPE LINER. FROM THESE, EIGHT HUNDRED AND FIVE (805) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: DISLOCATION/SUBLUXATION (X241), INFECTION (X190), PERIPROSTHETIC FRACTURE (X222), ASEPTIC LOOSENING (X63), IMPLANT MALALIGNMENT (X62), PAIN (X27), OTHER-UNSPECIFIED REASONS (X39), ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (X17), WEAR OF ACETABULAR COMPONENT (X13), IMPLANT FRACTURE (X18), OSTEOLYSIS (X12), DISSOCIATION OF LINER (X5), UNEQUAL LIMB LENGTH (X5) AND IMPLANT MISMATCH (X6). NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 24-APR-2008 AND 26-FEB-2025 IN THE UNITED KINGDOM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE R3 ACETABULAR SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. ACCORDING TO THIS REGISTRY REPORT, A TOTAL OF SIXTY-FIVE THOUSAND THREE HUNDRED AND TWENTY-NINE (65,329) PRIMARY THA PROCEDURES WITH R3 XLPE INSERTS HAVE BEEN PERFORMED IN THE UNITED KINGDOM BETWEEN 24-APR-2008 AND 26-FEB-2025. THE MEAN CUMULATIVE REVISION RATES FOR THE R3 XLPE INSERTS WERE IN LINE WITH THE MEAN CUMULATIVE REVISION RATES FOR THE THA NJR CLASS ACROSS ALL YEARS OF FOLLOW-UP DATA AVAILABLE. THE FOLLOWING CUMULATIVE REVISION RATES WITH 95% CONFIDENCE INTERVALS ARE PRESENTED IN THIS REPORT: O AT 1ST POSTOPERATIVE YEAR: 0.73% (0.66%-0.80%) VS 0.79% (0.78%-0.81%) OF THE CLASS.O AT 3RD POSTOPERATIVE YEAR: 1.05% (0.96%-1.13%) VS 1.42% (1.40%-1.44%) OF THE CLASS.O AT 5TH POSTOPERATIVE YEAR: 1.30% (1.20%-1.40%) VS 2.0% (1.97%-2.02%) OF THE CLASS.O AT 10TH POSTOPERATIVE YEAR: 1.94% (1.78%-2.12%) VS 3.74% (3.70%-3.78%) OF THE CLASS.O AT 15TH POSTOPERATIVE YEAR: 2.99% (2.21%-4.04%) VS 6.02% (5.95%-6.09%) OF THE CLASS.BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Additional Manufacturer Narrative · 0

CORRECTED DATA: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT 1020279-2025-00946, PREVIOUSLY SUBMITTED ON OCTOBER 23, 2025. SPECIFICALLY, THE FOLLOWING COMPLAINTS: -(B)(4). ADDITIONAL DETAILS FOR EACH UNIQUE COMPLAINT ID NUMBER WERE ADDED: EVENT DATE, GENERIC NAME, MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, UDI NUMBER, EVENT DESCRIPTION, MEDICAL HISTORY, PATIENT AGE, PATIENT GENDER, PATIENT WEIGHT, DATE IMPLANTED, DATE EXPLANTED, HEALTH EFFECT CLINICAL CODE, AND DEVICE PROBLEM CODE. ALSO, IN B5 (EVENT NARRATIVE) TIMEFRAME OF IMPLEMENTATIONS FOR THE REFLECTION XLPE ACETABULAR LINERS WERE CORRECTED TO: - REFLECTION XLPE ACETABULAR LINER IN PRIMARY SURGERIES: (B)(6) 2004 AND (B)(6) 2025. - REFLECTION XLPE ACETABULAR LINER IN REVISION SURGERIES: (B)(6) 2004 AND (B)(6) 2015. NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE.CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT 1020279-2025-00946.

Additional Manufacturer Narrative · 0

CORRECTED DATA: B5 (EVENT NARRATIVE), D1 (¿R3 XLPE INSERT¿ REMOVED FROM BRAND NAME, AS THE 3500A FORM INCORPORATES SEVERAL PRODUCTS), H2 (TOTAL QUANTITY OF SUMMARIZED EVENTS IS NOW 1,587), H6 (ADDITIONAL CODES ADDED FOR ¿HEALTH EFFECT - CLINICAL CODE¿ AND ¿MEDICAL DEVICE PROBLEM CODE¿ PERTAINING TO THE ADDITIONAL EVENTS INCORPORATED TO THIS 3500A FORM SUBMISSION). H11: THIS REPORT IS SUBMITTED IN RESPONSE TO THE FDA¿S OBSERVATIONS REGARDING SMITH+NEPHEW¿S (S+N) SUMMARY MDR REPORTING PRACTICES UNDER RWD2300584, COMMUNICATED ON JULY 1, 2025. AS A RESULT, THE MDR WITH REFERENCE 1020279-2025-00946 INCORPORATES ALL THE REAL WORD DATA SHARING THE FOLLOWING BUNDLING CRITERIA: REGISTRATION NUMBER: (B)(4), DATA SOURCE: NATIONAL JOINT REGISTRY (NJR), REPORT TYPE: SERIOUS INJURY, PRODUCT CLASSIFICATION CODE: JDI. ADDITIONAL COMPLAINTS HAVE BEEN ADDED SINCE THE PREVIOUS SUBMISSION ON (B)(6) 2025: (B)(4). EXCEPT FOR THE CORRECTED FIELDS NOTED ABOVE UNDER ¿CORRECTED DATA¿, THE INFORMATION PROVIDED IN THE REQUIRED FIELDS OF THE PRIOR 3500A FORM SUBMITTED ON 25-MAY-2025 REMAINS UNCHANGED. REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY (THA): 1. PRIMARY THA PROCEDURES - R3 XLPE ACETABULAR LINER: A TOTAL OF SIXTY-FIVE THOUSAND THREE HUNDRED AND TWENTY-NINE (65,329) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 24-APR-2008 AND 26-FEB-2025, USING AN R3 XLPE LINER. FROM THESE, EIGHT HUNDRED AND FIVE (805) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: DISLOCATION/SUBLUXATION (241), INFECTION (190), PERIPROSTHETIC FRACTURE (222), ASEPTIC LOOSENING (63), IMPLANT MALALIGNMENT (62), PAIN (27), OTHER-UNSPECIFIED REASONS (39), ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (17), WEAR OF ACETABULAR COMPONENT (13), IMPLANT FRACTURE (18), OSTEOLYSIS (12), DISSOCIATION OF LINER (5), UNEQUAL LIMB LENGTH (5) AND IMPLANT MISMATCH (6). IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - CPCS FEMORAL STEM: A TOTAL OF SIXTEEN THOUSAND SIX HUNDRED AND SEVENTY-FOUR (16,674) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 6-MAY-2003 AND 31-MAR-2025, USING A CPCS STEM. FROM THESE, THREE HUNDRED AND EIGHTY-SIX (386) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY (20) HIPS DUE TO UNEXPLAINED PAIN, SEVENTY-FIVE (75) HIPS DUE TO DISLOCATION/SUBLUXATION, THIRTY-EIGHT (38) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, FIFTY-THREE (53) HIPS DUE TO INFECTION, THIRTY-SEVEN (37) HIPS DUE TO ASEPTIC LOOSENING OF THE STEM, NINETY-FOUR (94) HIPS DUE TO ASEPTIC LOOSENING OF THE CUP, ONE HUNDRED AND ONE (101) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, TEN (10) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE CUP, FOUR (4) HIPS DUE TO MALALIGNMENT OF THE STEM, EIGHTEEN (18) HIPS DUE TO MALALIGNMENT OF THE SOCKET, TWO (2) HIPS DUE TO LEG LENGTH DISCREPANCY, THIRTY-SEVEN (37) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, TWENTY (20) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, THIRTY-SIX (36) HIPS DUE TO LYSIS ASSOCIATED WITH THE CUP, ONE (1) HIP DUE TO IMPLANT FRACTURE OF THE CERAMIC HEAD, TWO (2) HIPS DUE TO IMPLANT FRACTURE OF THE CERAMIC LINER, TWO (2) HIPS DUE TO IMPLANT FRACTURE OF THE POLY LINER, FOUR (4) HIPS DUE TO DISSOCIATION OF THE LINER, AND TWELVE (12) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - REFLECTION XLPE ACETABULAR LINER: A TOTAL OF ONE THOUSAND NINE HUNDRED AND FOUR (1,904) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 01-JAN-2004 AND 27-MAY-2025, USING A REFLECTION XLPE LINER. FROM THESE, THIRTY (30) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, SIX (6) HIPS DUE TO INFECTION, SIX (6) HIPS DUE TO PAIN, SIX (6) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO MALALIGNMENT ASSOCIATED WITH THE SOCKET, TWO (2) HIPS DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO INCORRECT SIZING HEAD, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET AND ONE (1) HIP DUE TO OTHER/UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - REFLECTION XLPE ALL-POLY CUP: A TOTAL OF THREE THOUSAND THREE HUNDRED FIFTY-FOUR (3,354) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 13-SEP-2006 AND 18-APR-2025, USING A REFLECTION XLPE ALL-POLY CUP. FROM THESE, FIFTY-SIX (56) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TEN (10) HIPS DUE TO LOOSENING ¿ SOCKET, TWELVE (12) HIPS DUE TO DISLOCATION/SUBLUXATION, FOURTEEN (14) HIPS DUE TO INFECTION, ONE (1) HIP DUE TO UNEXPLAINED PAIN, FOUR (4) HIPS DUE TO MALALIGNMENT SOCKET, NINETEEN (19) HIPS DUE TO PERI-PROSTHETIC FRACTURE STEM, FOUR (4) HIPS DUE TO LOOSENING STEM, TWO (2) HIPS DUE TO MALALIGNMENT STEM, ONE (1) HIP DUE TO LYSIS ¿ STEM, ONE (1) HIP DUE TO LYSIS ¿ SOCKET, TWO (2) HIPS DUE TO PERI-PROSTHETIC FRACTURE SOCKET, THREE (3) HIPS DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS AND TWO (2) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTEDFOR A SINGLE REVISION PROCEDURE. - ANTHOLOGY FEMORAL STEM: A TOTAL OF SEVEN THOUSAND AND EIGHTY-FIVE (7085) HIPS UNDERWENT PRIMARY THA BETWEEN 21-AUG-2006 AND 21-MAY-2025, USING AN ANTHOLOGY FEMORAL COMPONENT. FROM THESE, THREE HUNDRED ONE (301) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED TWELVE (112) JOINTS DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, THIRTY-SEVEN (37) JOINTS DUE TO INFECTION, THIRTY-THREE (33) JOINTS DUE TO DISLOCATION/SUBLUXATION, THIRTY-TWO (32) JOINTS DUE TO OTHER-UNKNOWN REASONS, TWENTY-SIX (26) JOINTS DUE TO ASEPTIC LOOSENING OF THE STEM, TWENTY (20) JOINTS DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, FIFTEEN (15) JOINTS DUE TO MALALIGNMENT OF THE SOCKET, FOURTEEN (14) JOINTS DUE TO PAIN, EIGHT (8) JOINTS DUE TO MALALIGNMENT OF THE STEM, EIGHT (8) JOINTS DUE TO PERIPROSTHETIC FRACTURE, SEVEN (7) JOINTS DUE TO WEAR OF THE ACETABULAR COMPONENT, SIX (6) JOINTS DUE TO ASEPTIC LOOSENING OF THE SOCKET, FOUR (4) JOINTS DUE TO LYSIS OF THE SOCKET, THREE (3) JOINTS DUE TO DISSOCIATION OF THE LINER, THREE (3) JOINTS DUE TO LYSIS OF THE STEM, THREE (3) JOINTS DUE TO PERIPROSTHETIC FRACTURE OF THE SOCKET, TWO (2) JOINTS DUE TO IMPLANT FRACTURE OF THE STEM, TWO (2) JOINTS DUE TO LEG LENGTH DISCREPANCY, ONE (1) JOINT DUE TO IMPLANT FRACTURE OF A CERAMIC COMPONENT IN THE STEM, ONE (1) JOINT DUE TO INCORRECT SIZING OF THE HEAD, AND ONE (1) JOINT DUE TO INCORRECT SIZING OF THE SOCKET. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ACCORDING TO THE NJR MONTHLY DATA DOWNLOAD REVIEWED, AT LEAST ONE HUNDRED FIVE (105) REVISIONS INVOLVED THE USE OF R3 XLPE ACETABULAR LINERS AT PRIMARY, AS REFERENCED THROUGH THIS REPORT. ADDITIONALLY, ONE (1) REVISION INVOLVED THE USE OF A REFLECTION XLPE ACETABULAR LINER AT PRIMARY THA. SINCE THESE ONE HUNDRED SIX (106) REVISIONS ARE ALREADY COUNTED AS INDIVIDUAL EVENTS BASED ON THE NUMBER OF REVISIONS REPORTED FOR THE CORRESPONDING ACETABULAR LINERS, ONLY ONE HUNDRED FIVE (195) REVISIONS WILL BE ADDED TO THE TOTAL NUMBER OF EVENTS REPORTED IN THE ¿NUMBER OF EVENTS¿ FIELD IN SECTION H2 OF THE 3500A FORM. 2. REVISION THA PROCEDURES - R3 XLPE ACETABULAR LINER: A TOTAL OF EIGHT HUNDRED NINETY-EIGHT (898) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 10-SEP-2008 AND 07-FEB-2025, USING AN R3 XLPE ACETABULAR LINERS. FROM THESE, SEVENTY-EIGHT (78) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: DISLOCATION/SUBLUXATION (19), INFECTION (17), ASEPTIC LOOSENING (21), PERIPROSTHETIC FRACTURE (12), PAIN (10), ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (6), MALALIGNMENT OF IMPLANT (2), WEAR OF ACETABULAR COMPONENT (2), OTHER-UNKNOWN REASONS (2) AND OSTEOLYSIS ASSOCIATED WITH THE FEMORAL STEM (1). IT SHOULD BE NOTED THAT MORE THAN ONE REASON MAY BE LISTED FOR EACH REVISION SURGERY. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - REFLECTION XLPE ACETABULAR LINER: A TOTAL OF ONE HUNDRED AND NINETY-TWO (192) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 01-JAN-2004 AND 31-DEC-2015, USING A REFLECTION XLPE LINER. FROM THESE, TWENTY-SEVEN (27) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: EIGHT (8) HIPS DUE TO INFECTION, SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, FOUR (4) HIPS DUE TO PAIN, THREE (3) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, THREE (3) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THREE (3) HIPS DUE TO IMPLANT FRACTURE ASSOCIATED WITH THE FEMORAL STEM, TWO (2) HIPS DUE TO OTHER/UNKNOWN REASONS, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET AND ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION SURGERY. - SPECTRON FEMORAL STEM: A TOTAL OF EIGHTY-ONE (81) HIPS UNDERWENT THA REVISION PROCEDURES UPON WHICH A SPECTRON STEM WAS PLACED IN EXCHANGE OF THE PRIMARY FEMORAL COMPONENT BETWEEN 15-APR-2003 AND 22-FEB-2023. FROM THESE, FOUR (4) HIPS WERE RE-REVISED DUE TO THE FOLLOWING REASONS: ONE (1) OF THEM DUE TO ADVERSE SOFT TISSUE REACTION, TWO (2) DUE TO FEMORAL STEM ASEPTIC LOOSENING, AND TWO (2) DUE TO ACETABULAR SOCKET ASEPTIC LOOSENING. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION SURGERY. - REFLECTION XLPE ALL-POLY CUP: A TOTAL OF FIFTY (50) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 23-JAN-2007 AND 8-JAN-2025, USING A REFLECTION XLPE ALL-POLY CUP. FROM THESE, SIX (6) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO UNEXPLAINED PAIN, ONE (1) HIP DUE TO LYSIS ¿ STEM, ONE (1) HIP DUE TO LYSIS ¿ SOCKET, ONE (1) HIP DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS, ONE (1) HIP DUE TO PERI-PROSTHETIC FRACTURE ¿ STEM, TWO (2) HIPS DUE TO INFECTION AND ONE (1) HIP DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 1,472 REVISIONS AND 115 RE-REVISIONS (1,587 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE NATIONAL JOINT REGISTRY (NJR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE R3 ACETABULAR SYSTEM, CPCS HIP STEM, SPECTRON EF HIP SYSTEM, REFLECTION ACETABULAR SYSTEM, REFLECTION ALL-POLY XLPE CUP AND ANTHOLOGY HIP SYSTEM PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. NATIONAL JOINT REGISTRY (NJR) INDUSTRY SUMMARY REPORTS OR THE NJR MONTHLY DATA DOWNLOAD FOR THE SMITH+NEPHEW PROSTHESES REFERENCED ABOVE WERE REVIEWED FOR THE CORRESPONDING THA PROCEDURES ANALYZED. FOR BOTH PRIMARY THA AND REVISION THA IMPLANTATIONS, THE MEAN KAPLAN-MEIER REVISION RATE AT ACROSS ALL YEARS OF FOLLOW-UP FOR R3 XLPE ACETABULAR LINER WERE SIGNIFICANTLY LOWER FROM THE CLASS DEVICE, BASED ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. THE CPCS STEMS SURVIVORSHIP WAS IN LINE WITH THE CLASS FOR CURRENT ON-LABEL USAGE. THE NJR SHOWED CPCS STEMS WERE USED IN OFF-LABEL COMBINATIONS WITH OTHER MANUFACTURER¿S LINERS. REVISION RATES FOR ON-LABEL USAGE WITH CERAMIC AND POLYETHYLENE INSERTS WAS IN LINE WITH THE CLASS. CPCS STEMS UTILIZED WITH SMITH & NEPHEW METAL-ON-METAL WERE REVISED IN 40% OF THE CASES. IT IS IMPORTANT TO NOTE THAT THE METAL-ON-METAL OPTION IS NO LONGER AVAILABLE FOR CPCS COCR STEMS. CUMULATIVE REVISION RATES OF REFLECTION XLPE ACETABULAR LINERS AT 1 YEARS WERE IN LINE WITH THE CLASS, BASED ON OVERLAPPING CONFIDENCE INTERVALS. BETWEEN 3 AND 15 YEARS, THESE LINERS DEMONSTRATED BETTER (LOWER) CUMULATIVE REVISION RATES THAN THE CLASS DEVICE OF ALL PRIMARY THA CAPTURED IN THE NJR WHEN CONSIDERING THE NON-OVERLAPPING CONFIDENCE INTERVALS. SIMILARLY, CUMULATIVE RE-REVISION RATES OF REFLECTION XLPE ACETABULAR LINERS WERE ALL IN LINE WITH THE CLASS DEVICE OF ALL REVISION THA CAPTURED IN THE NJR BASED ON THE OVERLAPPING CONFIDENCE INTERVALS ACROSS 15 YEARS OF FOLLOW-UP. CUMULATIVE REVISION RATES OF REFLECTION XLPE ALL-POLY CUP AT ALL TIME POINTS FROM 1 TO 13 FOLLOW-UP YEARS ARE IN LINE WITH THE ALL-OTHER CEMENTED CUPS IN NJR CLASS, AS DEFINED BY OVERLAPPING CONFIDENCE INTERVALS. THE SAME PERFORMANCE WAS OBSERVED AT ALL TIME POINTS FROM YEAR 1 TO 10, IN THE RE-REVISION RATE OF THE REFLECTION ALL-POLY XLPE CUP, WHICH WAS IN LINE WITH THE CLASS, AS DEFINED BY OVERLAPPING CONFIDENCE INTERVALS. HOWEVER, DUE TO THE LOW NUMBER OF PATIENTS AT RISK IN THE REFLECTION ALL-POLY XLPE CUP GROUP, THIS DATA MAY NOT BE STATISTICALLY STRONGLY RELIABLE. THE LOW NUMBER OF PATIENTS AT RISK ALSO CONTRIBUTES TO THE OBSERVED LARGE CONFIDENCE INTERVALS. THE CUMULATIVE REVISION RATES FOR THE ANTHOLOGY FEMORAL STEMS ARE IN LINE WITH THE CLASS AS DEMONSTRATED BY OVERLAPPING CONFIDENCE ACROSS ALL YEARS OF FOLLOW-UP, WITH THE EXCEPTION OF THE 10 YEARS OF FOLLOW UP. THE CLASS WAS CONSIDERED FROM THE 21ND NJR ANNUAL REPORT 2024 ALL UNCEMENTED STEMS. THE MOST FREQUENT REASON FOR REVISION WAS ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (1,58%), FOLLOWED BY INFECTION (0.52%) AND DISLOCATION/SUBLUXATION (0.47%). A POTENTIAL REASON FOR THE ELEVATED REVISION RATE AT 10 YEARS OF FOLLOW UP COULD BE DUE TO THE OBSERVED RATE OF REVISIONS FOR REACTION TO METAL DEBRIS WHICH MAY HAVE COME FROM THE SELECTION OF BEARING MATERIALS AND NOT RELATED TO THE STEM. IT SHOULD BE NOTED THAT, OUT OF THE 112 REVISIONS LISTING ¿ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS¿ AS A REASON FOR REVISION, 108 REVISIONS INVOLVED A METAL-ON-METAL BEARING WHICH IS NO LONGER MANUFACTURED BY SMITH+NEPHEW. A TOTAL OF EIGHTY-ONE (81) REVISION THA IMPLANTATIONS WITH THE SPECTRON FEMORAL STEM WERE PERFORMED IN THE UNITED KINGDOM BETWEEN 15-APR-2003 AND 22-FEB-2023. THE MEAN CUMULATIVE RE-REVISION RATES FOR SPECTRON EF REVISION STEM WERE SIGNIFICANTLY LOWER THAN THOSE FOR THE CEMENTED STEMS THR CLASS IN THE NJR AT 2 YEARS OF FOLLOW-UP AND ONWARDS, AS INDICATED BY THE NON-OVERLAPPING CONFIDENCE INTERVALS. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00267329-1-L1,7/27/2010,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 48MM,71334948,07KN17042,71334948, ,03596010598103,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Trendelenburg gait and other unspecified reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female,54,5/17/2010, ,E2302,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L2,7/5/2011,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,08fm15631,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,5/24/2011, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L3,7/25/2011,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,09FM19682,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Female, ,7/20/2011, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L4,8/1/2011,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,08GM08427,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other (please specify); Osteoarthritis; D,85,Male, ,9/14/2010, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L5,8/2/2011,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,09b,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Male, ,7/21/2011, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L6,11/29/2011,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,08LM16011,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female,64,11/15/2011, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L7,12/12/2011,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,08LM09082,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Male, ,8/1/2011, ,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L8,3/26/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,10jm05387,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Male,73,12/12/2011, ,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L9,3/30/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,11BM14736,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male, ,1/6/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L10,5/24/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 52MM,71337552,10jm00866,71337552, ,03596010615206,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,8/26/2011, ,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L11,7/6/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,11MM00862,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),46,Male, ,5/1/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L12,8/3/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,08LM03283C,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,41,Male, ,4/13/2012, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L13,8/15/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,08JM04275,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),75,Female, ,8/4/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L14,9/12/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,11GM10349,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male,95,4/4/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L15,10/1/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 52MM,71337552,09am21402,71337552, ,03596010615206,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,44,Female, ,9/10/2012, ,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L16,10/4/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 54MM,71337554,08GM11863,71337554, ,03596010615213,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,3/26/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L17,10/29/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 52MM,71337552,10HM14791,71337552, ,03596010615206,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female,53,12/21/2011, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L18,11/27/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,08gm11871,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Male, ,10/23/2012, ,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L19,11/30/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,08LM04104,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,44,Female, ,11/20/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L20,12/21/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,10JM17784,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,42,Male, ,4/13/2012, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L21,12/31/2012,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,10cm16081b,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,12/5/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L22,1/3/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,12GM06233,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Male,71,10/30/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L23,4/19/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 52MM,71337552,10JM00867,71337552, ,03596010615206,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male,101,4/10/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L24,5/15/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,12km19301,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,4/13/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L25,5/21/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,10HM19328,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Male,83,3/22/2011, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L26,5/31/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,12MM09668,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,5/22/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L27,7/1/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 56MM,71337556,07l,71337556, ,03596010615220,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,7/7/2011, ,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L28,7/12/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 58MM,71339558,10HM11234,71339558, ,03596010615268,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),69,Male, ,5/24/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L29,8/1/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,12BM06323,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,48,Female, ,1/31/2013, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L30,8/7/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,11DM05186,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,53,Male,132,2/20/2012, ,E2127;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L31,9/12/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,09BM05695,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,9/1/2011, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L32,9/25/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,13cm12737,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Female, ,8/23/2013, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L33,10/9/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,12HM00877,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Chronic,90,Female, ,8/8/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L34,10/22/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,12BM01373,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,10/9/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L35,10/25/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,12FM09333,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Male, ,11/23/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L36,10/25/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,12fm09324,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem and Lysis ¿ Socket and Infection and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,2/16/2013, ,E1627;E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L37,11/14/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,10hm00915,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,41,Male, ,7/13/2012, ,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L38,11/14/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,2MM08350,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female,61,9/3/2013, ,E2308;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L39,11/14/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,12mm13295,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,10/29/2013, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L40,11/19/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,11FM08462,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Male,90,11/20/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L41,11/19/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,12GM16433,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female,94,10/31/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L42,12/6/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,12jm03171,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,9/3/2013, ,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L43,12/12/2013,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 48MM,71337548,12KM01707,71337548, ,03596010598462,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female,90,8/6/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L44,1/21/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,13FM09187,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,47,Male,57,12/21/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L45,1/29/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,12jm12144,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,1/8/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L46,2/8/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,13gm12218,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,10/29/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L47,3/5/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,12lm04967,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,2/10/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L48,3/13/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,10gm14906,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male,107,11/19/2013, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L49,3/15/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,13gm06036,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Female, ,3/11/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L50,4/9/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,3KM13195,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female,62,2/19/2014, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L51,4/11/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,12AM06803,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Male, ,3/24/2012, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L52,4/24/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,13jm05996,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,3/3/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L53,6/27/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,12AM08400,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male, ,6/26/2012, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L54,6/30/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,12JM04241,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,50,Female, ,2/27/2013, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L55,7/17/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14cm12857,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,57,Female, ,7/7/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L56,7/31/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 48MM,71334948,08FM06084,71334948, ,03596010598103,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female,85,7/2/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L57,8/8/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14cm08110,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,6/4/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L58,8/8/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,10DM16732,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,6/26/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L59,9/11/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,12LMO8758,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),63,Male, ,5/27/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L60,10/6/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,11JM10305,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,8/28/2014, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L61,10/9/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,08jm00927,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis; Other,70,Male, ,10/9/2009, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L62,10/9/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 52MM,71337552,08lm09752,71337552, ,03596010615206,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,2/10/2014, ,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L63,10/22/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14am17326,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male,75,4/23/2014, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L64,10/27/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,13jm00647,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,48,Male, ,1/2/2014, ,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L65,11/3/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,13JM05997,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female, ,11/25/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L66,11/7/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,13fm16167,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female,61,2/11/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L67,11/13/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,14EM11758,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),59,Male, ,10/22/2014, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L68,11/25/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,07LM08023,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Seropositive Rheumatoid Arthritis,64,Female, ,11/18/2008, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L69,11/26/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,12MM11752,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),80,Male, ,7/23/2013, ,E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L70,12/2/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,13lm01281,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,3/4/2014, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L71,12/4/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,12GM16424,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other,80,Male, ,9/30/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L72,12/23/2014,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,14dm141554,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Male, ,11/27/2014, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L73,1/6/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 62MM,71332762,07LM16880,71332762, ,03596010598035,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Male, ,8/31/2011, ,E2127;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L74,1/20/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,12DM10028,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,7/2/2013, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L75,1/23/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,08MM07184,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket and Implant Fracture ¿ head and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Male, ,1/20/2015, ,E161201,F1905,A0102;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L76,2/6/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,12CM07300,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,5/1/2013, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L77,2/17/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,11GM12217,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,3/20/2012, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L78,2/19/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14GM20807,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Female, ,1/29/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L79,2/27/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14GM15215,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Metastatic Cancer/Malignancy,60,Male, ,2/2/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L80,2/27/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,14jm12669,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female,77,2/18/2015, ,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L81,3/18/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 62MM,71337662,14BM04898,71337662, ,03596010598547,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis; Other,67,Male, ,2/11/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L82,3/20/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,13KM01039,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,1/31/2014, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L83,3/21/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 52MM,71337552,10km02589,71337552, ,03596010615206,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female,65,9/19/2011, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L84,4/1/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,08hm11812,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Male, ,2/6/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L85,4/8/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,13MM02767,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,2/5/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L86,4/10/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14CM00230,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female, ,1/30/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L87,4/13/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,14am12068,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,9/8/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L88,4/29/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14lm02780,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,71,Female, ,3/26/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L89,5/13/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,13HM14939,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,3/13/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L90,5/14/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14GM16175,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),32,Male, ,5/7/2015, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L91,5/15/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14HM05233,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis; Trauma - Chronic,76,Male, ,3/20/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L92,5/26/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,13FM07490,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male, ,10/26/2014, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L93,6/5/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,08HM03401,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,10/16/2014, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L94,6/22/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,14CM08118,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),73,Male, ,4/5/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L95,6/26/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,13LM03647,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,49,Male, ,4/24/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L96,7/16/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,15AM05985,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,41,Female, ,4/9/2015, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L97,7/18/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,14bm04438,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female, ,6/30/2015, ,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L98,7/28/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 46MM,71337546,14fm05581,71337546, ,03596010598455,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Female,47,2/27/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L99,8/6/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,15AM11026,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Female, ,6/24/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L100,8/8/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,14AM20110,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Male, ,8/5/2014, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L101,9/15/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15DM20252,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male, ,8/26/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L102,9/17/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15EM12569,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Female, ,9/11/2015, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L103,9/19/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,15DM20254,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Male,78,8/4/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L104,10/7/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,15fm02188,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Female,63,9/25/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L105,10/15/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14FM08625,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female, ,9/25/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L106,10/29/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,15gm07080,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,53,Female, ,10/22/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L107,11/3/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,13dm08640,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male,97,10/16/2015, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L108,11/6/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,15GM08959,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),77,Female, ,10/21/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L109,11/10/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,11LM00635,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,53,Female, ,4/10/2012, ,E1614,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L110,11/16/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,14am18088,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Male, ,10/13/2014, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L111,11/17/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 56MM,71337556,08LM06032,71337556, ,03596010615220,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Female, ,2/24/2010, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L112,11/23/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 60MM,71334960,2CM16771,71334960, ,03596010598172,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture ¿ head.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,48,Male,75,7/7/2015, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L113,11/23/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 48MM,71334948,12am16599,71334948, ,03596010598103,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,49,Female, ,11/5/2015, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L114,11/24/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,15FM19168,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male,91,11/16/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L115,11/25/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,15EM15712,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,10/27/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L116,12/5/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14hm06295,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Male, ,12/2/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L117,12/7/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,12mm06812,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,3/24/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L118,12/15/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,15EM05471,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,11/23/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L119,12/16/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,15em16567,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,9/7/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L120,12/18/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,14FM19397,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,8/19/2015, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L121,12/22/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,15gm08223,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,12/8/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L122,12/22/2015,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,15gm08223,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,12/8/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L123,1/7/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,14BM15958,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,92,Male, ,10/16/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L124,1/16/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,15GM15580,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male, ,1/11/2016, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L125,2/4/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,14EM09582,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,60,Male, ,4/20/2015, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L126,2/22/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,08fm11922,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male,91,11/19/2013, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L127,3/21/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15lm18874,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,3/16/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L128,3/22/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 22MM X 40MM,71334940,07LM11067,71334940, ,03596010598066,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip,29,Female, ,10/29/2013, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L129,4/11/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,13DM02510,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,57,Female, ,8/27/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L130,4/12/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,07MM06808,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male,113,12/29/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L131,4/21/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 62MM,71332762,2LM11869,71332762, ,03596010598035,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male,92,4/10/2014, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L132,5/10/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,15KM19464,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,4/19/2016, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L133,5/17/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 48MM,71337548,13DM06559,71337548, ,03596010598462,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,8/19/2014, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L134,6/7/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,13CM03859,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Male, ,9/22/2015, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L135,6/15/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,16BM09990,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,6/9/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L136,6/16/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,5EM1656,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female, ,8/10/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L137,7/13/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,15bm03775,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female, ,6/18/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L138,7/14/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,16am03845,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Male,117,6/10/2016, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L139,7/19/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,14FM18056,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,7/8/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L140,7/28/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,15hm07278,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,6/20/2016, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L141,8/2/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,16BM19842,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Male,88,7/25/2016, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L142,8/10/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,15am05985,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female, ,5/6/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L143,8/11/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,15LM18863,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,49,Female, ,6/6/2016, ,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L144,8/15/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 58MM,71339558,13jm05953,71339558, ,03596010615268,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Male, ,10/17/2015, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L145,8/23/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,16bm05994,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male,65,7/26/2016, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L146,9/5/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,13JM05998,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Female, ,12/18/2013, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L147,10/3/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14FM08620,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Male, ,12/8/2014, ,E161201;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L148,10/31/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,10hm19280,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,12/6/2010, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L149,11/1/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,16fm13941,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Male, ,9/19/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L150,11/2/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,16em21528,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Male,95,10/19/2016, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L151,11/5/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,15HM02293,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male,77,7/29/2016, ,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L152,11/7/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,15gm03778,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,60,Male, ,11/3/2015, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L153,11/12/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,16am09393,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,11/1/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L154,11/25/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,15LM00839,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis; Other,64,Male,85,11/9/2016, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L155,11/30/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,14hm21530,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Female, ,2/10/2015, ,E1614;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L156,12/12/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 60MM,71334960,10DM09633,71334960, ,03596010598172,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male,73,12/10/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L157,12/19/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,16DM21627,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Chronic,46,Male,95,11/28/2016, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L158,12/30/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,16CM17915,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),78,Male, ,12/2/2016, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L159,12/31/2016,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,16gm19824,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,12/30/2016, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L160,1/16/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,12EM09709,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Female, ,9/22/2015, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L161,2/3/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,14BM03382,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Female, ,7/10/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L162,2/10/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,14JM10717,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Male,98,1/25/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L163,3/21/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,16km01769,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,2/28/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L164,3/31/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,12BM16454,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male,61,3/29/2017, ,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L165,4/2/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,16LM15019,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female,54,3/21/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L166,4/6/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,15EM08222,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Female,104,8/13/2015, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L167,4/6/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,16dm,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male, ,3/21/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L168,4/18/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,16hm15356,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis; Trauma - Acute (e.g. Neck Of Femur),79,Male, ,2/17/2017, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L169,4/25/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15dm20250,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,9/9/2015, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L170,4/25/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,16lm10901,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,4/18/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L171,5/2/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,17AM07555,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female, ,4/7/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L172,5/4/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,14gm11332,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Female,81,2/18/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L173,5/16/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,15MM11171,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female, ,7/13/2016, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L174,5/22/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,14HM06299,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,3/4/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L175,5/25/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 58MM,71334958,08dm12800,71334958, ,03596010598158,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Male,89,6/26/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L176,6/11/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,12JM01950,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,5/17/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L177,6/15/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,12EM07178,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Chronic,52,Male, ,11/6/2012, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L178,6/26/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,5AM05987,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Male,87,7/2/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L179,6/30/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,08BM16856,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,6/8/2009, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L180,7/22/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,16mm06994,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,39,Female, ,7/12/2017, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L181,7/27/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,12EM07185,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,1/7/2013, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L182,7/31/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 48MM,71334948,16EM10399,71334948, ,03596010598103,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female,86,6/19/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L183,7/31/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,16EM21549,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip,33,Male, ,7/28/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L184,8/1/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,16em07095,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis; Previous Hip Surgery - Non Trauma Related,70,Male,120,9/14/2016, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L185,8/2/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,17BM02066,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,7/11/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L186,8/3/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,15LM13835,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis; Other,23,Female, ,3/24/2016, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L187,8/8/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,17DM15532,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,63,Male, ,7/27/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L188,8/11/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15k,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female, ,2/10/2016, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L189,8/16/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,16MM07006,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,3/27/2017, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L190,8/19/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,17DM18620,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Male, ,8/11/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L191,9/14/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,17dm10964,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other,75,Female, ,8/24/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L192,9/20/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,08FM18289,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,6/28/2011, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L193,9/20/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,16FM02412,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,3/21/2017, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L194,9/23/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,13MM10242,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female,70,4/23/2014, ,E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L195,9/25/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,11DM02496,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female, ,11/3/2011, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L196,10/2/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,16em02871,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem and Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,8/5/2016, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L197,10/5/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,11hm02305,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female, ,9/6/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L198,10/6/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,13FM14799,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,50,Female, ,12/29/2016, ,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L199,10/12/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,13cm12750,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Female, ,8/9/2013, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L200,10/12/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,14dm,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Loosening - socket and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Male, ,9/25/2017, ,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L201,10/24/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,17dm09642,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,9/22/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L202,10/28/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,17CM05564,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female, ,10/26/2017, ,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L203,11/2/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 22MM X 44MM,71334944,07lm07876,71334944, ,03596010598080,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,2/13/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L204,11/2/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,15FM19169,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female,70,4/7/2016, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L205,11/9/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,13KM15981,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Male,94,3/13/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L206,11/9/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,13mm16442,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,11/20/2014, ,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L207,11/9/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,17FM21471,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Male,100,10/26/2017, ,E161201;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L208,11/16/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,10LM17241,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,9/7/2011, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L209,11/17/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,15KM00996,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male,86,6/9/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L210,11/29/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,15MM14447,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female, ,7/21/2016, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L211,12/1/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,17CM12394,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female,68,11/14/2017, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L212,12/7/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,17GM15254,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,51,Male,82,11/23/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L213,12/26/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,17em03831,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female, ,12/4/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L214,12/28/2017,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,15FM06259,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Female, ,9/20/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L215,1/8/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,12CM16800,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,69,Male, ,12/19/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L216,1/9/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,12FM02724,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other,62,Female, ,1/13/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L217,1/10/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,17HM13926,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket and Peri-Prosthetic Fracture ¿ Stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,12/19/2017, ,E161201;E2127;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L218,1/15/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,13LM12512,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Female, ,11/25/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L219,1/15/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,14DM22641,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem and Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,2/11/2015,1/15/2018,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L220,1/15/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,17EM07750,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female, ,12/4/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L221,1/24/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,14AM02165,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male,72,1/5/2018, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L222,1/26/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,15k,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,51,Male, ,2/19/2016, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L223,2/7/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,17KM02135,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female, ,1/24/2018, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L224,2/14/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,16HM18197,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Male, ,6/7/2017, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L225,2/15/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,13JM05998,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Previous Arthrodesis; Osteoarthritis,61,Female, ,2/27/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L226,2/19/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 58MM,71337558,15CM18231,71337558, ,03596010615237,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male, ,1/31/2018, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L227,3/5/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,15em08222,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female,75,9/4/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L228,3/6/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,13fm16147,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female, ,2/17/2018, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L229,3/13/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,13km13186,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,6/16/2015, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L230,3/14/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,15DM20254,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female, ,2/28/2018, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L231,3/23/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,17cm08223,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,50,Female, ,11/29/2017, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L232,3/28/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,17km13350,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male, ,2/10/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L233,3/30/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,13EM08034,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male, ,10/9/2013, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L234,4/4/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,15FM19823,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male,75,10/25/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L235,4/9/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,12km11431,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Male, ,2/26/2016, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L236,4/24/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16CM14688,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Female,87,7/12/2016, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L237,4/24/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 48MM,71334948,17JM05733,71334948, ,03596010598103,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,2/28/2018, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L238,4/30/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,12mm09692,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Male,82,2/24/2014, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L239,5/11/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,16AM11003,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male, ,12/14/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L240,5/17/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,17km15648,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,3/22/2018,5/17/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L241,5/18/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,16MM04684,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male, ,3/14/2017, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L242,5/18/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,17BVM11435,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,6/21/2017, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L243,5/18/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18AM,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,80,Male, ,4/24/2018, ,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L244,5/30/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,1KM07452,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female, ,5/2/2018,5/30/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L245,6/14/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,16hm09053,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Male, ,11/12/2016,6/14/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L246,6/14/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,17km12814,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,6/8/2018,6/14/2018,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L247,6/15/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,17EM08469,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),69,Female, ,9/1/2017,6/15/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L248,6/20/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,13CM10746,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,6/27/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L249,6/26/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,16BM15468,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Male, ,6/1/2017,6/26/2018,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L250,7/13/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,18DM17783,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male, ,6/28/2018,7/13/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L251,7/18/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 66/68MM,71335766,10dm02380,71335766, ,03596010598400,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Male, ,11/12/2012,7/18/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L252,7/21/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,08JM13455,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Male, ,10/1/2012,7/21/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L253,8/3/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,18EM21248,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,7/30/2018,8/3/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L254,8/8/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,14EM07239,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male, ,5/17/2018,8/8/2018,E1614;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L255,8/9/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,13KM20949,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,61,Male, ,7/3/2014,8/9/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L256,8/21/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,13km20951,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Male,94,11/3/2015,8/21/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L257,8/21/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,17CM12150,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,11/22/2017,8/21/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L258,8/29/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14gm11329,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,11/17/2014, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L259,8/30/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,13JM09973,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),59,Male, ,8/28/2014,8/30/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L260,9/4/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,17dm09653,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Female,88,8/16/2018,9/4/2018,E1614;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L261,9/11/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,15em00352,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male,98,6/1/2016, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L262,9/11/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,16jm17617,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,49,Male, ,1/18/2017, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L263,9/14/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,10MM09733,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,67,Female, ,8/3/2012,9/14/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L264,9/15/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,18EM21854,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male, ,7/31/2018,9/15/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L265,10/3/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,18FM16481,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Previous Hip Surgery - Non Trauma Related,63,Female, ,9/13/2018, ,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L266,10/9/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 62MM,71332762,15GM12068,71332762, ,03596010598035,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),74,Male, ,6/5/2018,10/9/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L267,10/11/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,16mm04080,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Male, ,8/13/2018, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L268,10/17/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,16CM18956,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male, ,6/28/2016,10/17/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L269,10/29/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,16KM00652,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Male,109,8/7/2017,10/29/2018,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L270,10/31/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,17MM10154,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),82,Female, ,8/22/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L271,11/12/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,17BM02103,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,91,Male, ,7/13/2017, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L272,11/16/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16HM01686,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,4/13/2017, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L273,11/17/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,18DM14495,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Male, ,8/3/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L274,11/20/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,15JM15984,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Wear of Acetabular Component and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,10/18/2016,11/20/2018,E2308;E040203,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L275,11/23/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 48MM,71334948,18GM18396,71334948, ,03596010598103,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,11/7/2018,11/23/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L276,11/23/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,18BM12465,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,11/9/2018, ,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L277,11/25/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,16fm23050,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,11/23/2018, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L278,11/26/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,16cm18582,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,10/8/2018,11/26/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L279,11/28/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,18fm07444,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,11/16/2018,11/28/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L280,12/5/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,17jm16667,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,10/19/2018, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L281,12/7/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,18HM08371,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,11/14/2018,12/7/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L282,12/10/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,15LM03134,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Female,79,11/21/2016,12/10/2018,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L283,12/11/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,17bm13452,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem and Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Female, ,4/7/2017,12/11/2018,E1627;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L284,12/17/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,14jm18944,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female, ,6/22/2015,12/17/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L285,12/21/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18CM23551,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Female, ,8/9/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L286,12/21/2018,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,18hm09786,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male,80,10/15/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L287,1/4/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,18KM18094,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),73,Female, ,12/31/2018,1/4/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L288,1/11/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,18BM19113,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,91,Female, ,8/21/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L289,1/19/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,17MM12528,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,6/4/2018,1/19/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L290,1/21/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 60MM,71334960,09EM06528,71334960, ,03596010598172,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female,73,2/1/2017,1/21/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L291,1/22/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,17FM04460,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis; Perthes,58,Female, ,1/11/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L292,1/23/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,17KM02091,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,45,Male, ,2/21/2018, ,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L293,1/28/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,16HM15348,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,84,Female, ,10/17/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L294,1/31/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14DM18159,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,45,Female,82,7/23/2014, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L295,2/1/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,17EM11043,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,11/13/2017,2/1/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L296,2/1/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,16am09650,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female,81,1/5/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L297,2/6/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,12AM09165,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,7/24/2012,2/6/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L298,2/11/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,18bm21220,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male, ,12/10/2018,2/11/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L299,2/18/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,17km17349,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),80,Female, ,3/15/2018,2/18/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L300,2/20/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,17EM15818,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Female, ,12/16/2017,2/20/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L301,2/20/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,18MM10083,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,2/18/2019,2/20/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L302,2/21/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,18JM15922,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,1/25/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L303,2/26/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,18fm12725,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,1/28/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L304,2/28/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,15mm03755,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Female,70,8/19/2016,2/28/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L305,3/7/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,17km16715,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,2/8/2019,3/7/2019,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L306,3/8/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,09bm00258,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Male, ,10/21/2011,3/8/2019,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L307,3/8/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,5EM01886,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Male, ,7/30/2015,3/8/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L308,3/12/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,18KM18754,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,60,Male, ,1/15/2019,3/12/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L309,3/12/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,18dm22596,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,2/13/2019,3/12/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L310,3/14/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,18lm09770,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Male, ,1/22/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L311,3/19/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,12km15886,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,10/7/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L312,3/21/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,18gm00608,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,48,Male,81,10/9/2018,3/21/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L313,3/21/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,17km06955,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Chronic,51,Male, ,2/27/2019,3/21/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L314,3/25/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 58MM,71337558,08gm11867,71337558, ,03596010615237,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),68,Male, ,8/6/2012,3/25/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L315,3/27/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,17LM11009,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,60,Male, ,3/20/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L316,4/1/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,18jm15180,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female,114,12/18/2018,4/1/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L317,4/3/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,17CM03704,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female, ,12/1/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L318,4/3/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,18FM12744,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),81,Female, ,3/22/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L319,4/9/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,14em,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,4/27/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L320,4/17/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,11hm09071,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Female, ,4/7/2016, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L321,4/29/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,18lm11876,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female,64,1/28/2019,4/29/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L322,5/1/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,19CM00382,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female,69,4/30/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L323,5/10/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,18LM03756,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Metastatic Cancer/Malignancy,62,Female, ,1/25/2019,5/10/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L324,5/15/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14KM01739,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),80,Female, ,2/10/2015, ,E161201,F1905,A0102;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L325,5/15/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE LNR 40MM ID X 56OD,71338687,14BM04876,71338687, ,00885556113189,K093363, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male, ,9/12/2015, ,E161201,F1905,A0102;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L326,5/15/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,17BM18884,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Female, ,6/9/2017,5/15/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L327,5/23/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,11lm10987,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,9/29/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L328,5/23/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,19AM03065,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,3/23/2019,5/23/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L329,5/23/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,19CM00430,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female, ,5/19/2019,5/23/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L330,5/24/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,18dm01413,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem and Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,44,Male, ,2/20/2019, ,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L331,5/31/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,19AM10938,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female,70,5/10/2019,5/31/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L332,6/4/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,17KM02886,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Male,91,1/10/2019,6/4/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L333,6/6/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,19bm10668,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,5/30/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L334,6/11/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,13MM01803,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,2/26/2014, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L335,6/15/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,19cm14082,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,45,Female,57,6/10/2019, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L336,6/18/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,18AM01999,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male, ,6/7/2019,6/18/2019,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L337,6/24/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,18DM18436,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Male, ,10/2/2018,6/24/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L338,6/25/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,19bm10668,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Female, ,5/23/2019,6/25/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L339,7/4/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,17FM21459,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,53,Female, ,9/5/2018,7/4/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L340,7/19/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,19dm21064,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female, ,7/1/2019,7/19/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L341,7/22/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 60MM,71334960,18GM14343,71334960, ,03596010598172,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male,94,12/14/2018,7/22/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L342,7/30/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,14am02146,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,4/24/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L343,8/27/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 48MM,71334948,18GM18396,71334948, ,03596010598103,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male,65,6/18/2019,8/27/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L344,8/29/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,19dm10070,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female,78,8/7/2019, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L345,8/30/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,17JM01172,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male,96,1/30/2019,8/30/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L346,9/4/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,14bm04438,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip,25,Female,59,7/24/2019,9/4/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L347,9/4/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,18EM15169,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male,95,8/10/2019,9/4/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L348,9/9/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,13DM18059,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,8/12/2017, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L349,9/10/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,16FM15158,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female, ,8/15/2017,9/10/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L350,9/12/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,08BM20359,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female,91,11/18/2013,9/12/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L351,9/18/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,18BM04492,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,11/7/2018,9/18/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L352,9/23/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,18EM21260,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,11/20/2018,9/23/2019,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L353,9/24/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18mm12973,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Female, ,6/12/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L354,9/27/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14EM11759,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male, ,9/17/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L355,9/27/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,15HM05410,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),80,Female, ,2/11/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L356,9/30/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,19fm06160,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Female, ,9/4/2019,9/30/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L357,10/9/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,17FM01820,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,9/22/2017,10/9/2019,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L358,10/21/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,19AM23782,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,6/28/2019,10/21/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L359,10/29/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,13LM01282,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),90,Female, ,6/12/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L360,10/30/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14HM18426,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,51,Male, ,10/25/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L361,11/1/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,18bm14766,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,57,Male, ,2/26/2019,11/1/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L362,11/7/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,12bm04853,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male,70,5/13/2016,11/7/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L363,11/7/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19CM17080,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,9/6/2019,11/7/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L364,11/9/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19GM04479,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Female, ,9/18/2019,11/9/2019,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L365,11/12/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,15CM14005,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,6/2/2015, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L366,11/12/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,15MM04487,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,8/8/2016,11/12/2019,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L367,11/12/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,17CM04672,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female, ,12/1/2017,11/12/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L368,11/12/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,19GM14686,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem and Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),55,Female, ,10/30/2019, ,E2308;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L369,11/13/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,19GM01532,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Male, ,11/6/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L370,11/15/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,15gm03892,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,1/28/2016,11/15/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L371,11/16/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,17AM15806,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy; Osteoarthritis,63,Female, ,4/29/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L372,11/16/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,19bm05292,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female, ,11/14/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L373,11/18/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,19em08262,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,9/9/2019, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L374,11/20/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,19dm01647,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,7/6/2019,11/20/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L375,11/26/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,16em04091,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,11/16/2016, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L376,11/26/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 64MM,71332764,16AM11021,71332764, ,03596010598042,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,57,Male, ,4/2/2019,11/26/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L377,12/1/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,19jm05540,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female,158,11/28/2019,12/1/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L378,12/12/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,17FM12213,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female,109,9/7/2017, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L379,12/16/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,18gm19998,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female,78,1/24/2019,12/16/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L380,12/16/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,18em15138,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,5/10/2019,12/16/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L381,12/23/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,16mm04473,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,12/2/2019,12/23/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L382,12/30/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,14cm04710,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other,21,Female, ,7/23/2014,12/30/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L383,12/31/2019,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,19hm21064,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,12/13/2019,12/31/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L384,1/3/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,12KM15886,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),75,Male, ,8/30/2017,1/3/2020,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L385,1/6/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,18FM11316,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Female, ,9/17/2018,1/6/2020,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L386,1/7/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,16CM09560,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),67,Female, ,8/20/2019,1/7/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L387,1/22/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15DM20250,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Female,66,6/29/2015,1/22/2020,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L388,1/27/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,16jm14078,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Female,75,11/25/2017,1/27/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L389,1/28/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,07km24684,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,10/26/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L390,1/30/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,12em10642,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Male, ,7/25/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L391,2/11/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,18HM22792,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female, ,11/1/2018,2/11/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L392,2/13/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,19GM06406,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female, ,2/12/2020, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L393,2/14/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,19am15758,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Female, ,10/8/2019,2/14/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L394,2/19/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19DM27489,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,2/7/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L395,2/27/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,16DM02086,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,8/18/2016,2/27/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L396,2/27/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,19GM06405,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male, ,1/28/2020,2/27/2020,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L397,2/28/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,18EM04734,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Female,73,9/17/2018,2/28/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L398,2/29/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,18CM18277,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male, ,1/16/2020,2/29/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L399,3/10/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,17AM15751,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Chronic,54,Male, ,3/27/2018, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L400,3/12/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,19jm12195,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),79,Female, ,2/18/2020,3/12/2020,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L401,3/13/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,19jm05544,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),83,Female, ,2/19/2020,3/13/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L402,3/24/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,18fm02185,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,47,Male, ,3/10/2020,3/24/2020,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L403,3/31/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,19gm06409,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Male, ,2/28/2020,3/31/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L404,4/3/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,16JM01018,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Male, ,5/1/2017, ,E1614;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L405,4/21/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,17JM18949,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male,58,12/1/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L406,4/25/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,19HM,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),79,Female,69,3/5/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L407,4/29/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,19JM06569,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,2/12/2020,4/29/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L408,5/1/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,19JM23855,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),83,Female, ,4/29/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L409,5/27/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,19dm18856,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,43,Female, ,7/3/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L410,6/1/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,19JM05541,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Male, ,12/13/2019,6/1/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L411,6/4/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,18mm03353,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,7/15/2019, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L412,6/5/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,13JM06905,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,4/23/2014,6/5/2020,E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L413,6/16/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19am13912,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Female, ,3/7/2019,6/16/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L414,6/18/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,19em08122,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male,114,7/4/2019,6/18/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L415,7/6/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,18MM14406,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,9/13/2019,7/6/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L416,7/14/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,13EM16633,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Male, ,12/4/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L417,8/14/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,19F,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),43,Male, ,8/7/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L418,8/20/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,16DM21620,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),73,Male, ,9/9/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L419,8/26/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,18CM08641,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Trauma - Chronic; Other,73,Male, ,6/30/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L420,8/27/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,19mm04461,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female, ,8/6/2020,8/27/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L421,9/2/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,17EM03832,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Male, ,5/17/2019,9/2/2020,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L422,9/8/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,16BM16085,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,10/5/2017,9/8/2020,E1627;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L423,9/8/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18bm10720,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,24,Female, ,6/12/2018,9/8/2020,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L424,9/16/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19JM12242,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy; Osteoarthritis,83,Female, ,9/11/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L425,9/17/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,19CM20286,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,12/2/2019,9/17/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L426,10/2/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,19GM21974,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,50,Male, ,9/22/2020,10/2/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L427,10/5/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,19gm24219,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Head/Socket Mismatch - Head.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,10/2/2020, ,E2401,F1905,A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L428,10/6/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,19jm15407,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female, ,10/5/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L429,10/8/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,18BM06821,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male, ,9/7/2020,10/8/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L430,10/11/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,18EM20690,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male, ,10/10/2020,10/11/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L431,10/13/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,18JM07476,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,11/21/2018, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L432,10/20/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,13FM08372,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Male,83,1/28/2014,10/20/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L433,10/21/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,15am02832,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male, ,6/11/2015,10/21/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L434,10/21/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,16bm16184,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Female, ,5/11/2019,10/21/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L435,10/22/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,16MM04562,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem and Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,51,Female, ,12/12/2018,10/22/2020,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L436,10/28/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14em10321,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Female, ,11/8/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L437,11/4/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,19AM10940,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male,70,5/24/2019,11/4/2020,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L438,11/9/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,13EM15977,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female,50,10/15/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L439,11/9/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,17em09774,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female, ,6/13/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L440,11/10/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,12DM17401,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,11/16/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L441,11/10/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,18DM22593,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Female, ,8/28/2018,11/10/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L442,11/13/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,19DM21020,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Male, ,8/31/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L443,11/30/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,19jm18475,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Male, ,9/26/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L444,12/8/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,14gm11330,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,11/18/2014,12/8/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L445,12/9/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,19FM16586,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,11/18/2020,12/9/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L446,12/16/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,20em05036,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,11/27/2020,12/16/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L447,12/22/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,15lm03129,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,5/6/2016,12/22/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L448,12/23/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18mm09094,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female, ,10/17/2020,12/23/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L449,12/28/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,19EM08145,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,10/13/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L450,12/29/2020,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,15EM04983,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),86,Female, ,9/20/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L451,1/6/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,20km04476,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,12/10/2020, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L452,1/7/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,17FM11902,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Male, ,11/23/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L453,1/23/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 48MM,71334948,19AM23712,71334948, ,03596010598103,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,57,Female, ,10/31/2020,1/23/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L454,2/4/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,19AM23797,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Male, ,11/28/2020,2/4/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L455,2/12/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,08DM09485,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,6/24/2015,2/12/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L456,3/10/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,19gm01522,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,94,Male, ,2/17/2021,3/10/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L457,3/18/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,14am22507,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,53,Female, ,8/14/2014,3/18/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L458,3/20/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,20MM04655,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,3/18/2021, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L459,3/22/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,15cm03121,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,6/25/2015, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L460,4/8/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,17DM15439,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,53,Female, ,11/23/2017,4/8/2021,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L461,4/13/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,16dm15520,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Male, ,8/9/2020,4/13/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L462,4/21/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,17lm15591,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Chronic,69,Female,98,3/29/2018,4/21/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L463,4/28/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,18HM02405,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Male,95,10/31/2018,4/28/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L464,4/28/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,19GM25156,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,4/13/2021, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L465,5/20/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,11em00811,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,94,Female, ,6/21/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L466,5/22/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,18MM12561,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Male, ,5/14/2021,5/22/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L467,6/2/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18EM18370,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female,69,9/18/2018,6/2/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L468,6/17/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,19FM09121,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),67,Male,77,5/3/2021,6/17/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L469,6/23/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,18dm04443,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,6/25/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L470,6/26/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,21AM07116,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male, ,5/20/2021,6/26/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L471,6/27/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,13MM06334,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Male, ,4/27/2021,6/27/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L472,6/29/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,18km14855,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male, ,8/8/2019,6/29/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L473,6/30/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 50MM,71337550,19gm02850,71337550, ,03596010615190,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female,41,1/20/2020,6/30/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L474,7/5/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,18DM22424,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Female,75,9/14/2018,7/5/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L475,7/5/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,19DM13696,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Skeletal Dysplasia,24,Male, ,6/3/2021,7/5/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L476,7/8/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,19km05636,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),66,Female,62,12/20/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L477,7/8/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,19JM06565,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female, ,6/24/2021, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L478,7/17/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,17KM13350,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,3/31/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L479,8/2/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,17AM07202,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female, ,1/12/2018,8/2/2021,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L480,8/10/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,19AM00658,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,5/11/2021,8/10/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L481,8/11/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,15lm00837,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Female, ,10/3/2017,8/11/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L482,8/11/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,18GM18402,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female,66,10/7/2020,8/11/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L483,8/19/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,18mm06599,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,3/7/2019,8/19/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L484,8/31/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,19KM24189,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,2/17/2020, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L485,9/1/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 50MM,71337550,18mm06581,71337550, ,03596010615190,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Female, ,6/12/2019,9/1/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L486,9/2/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,17HM17732,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,91,Female, ,12/1/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L487,9/16/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,2HM03543,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,3/14/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L488,9/25/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,19FM01529,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female,94,1/10/2020,9/25/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L489,9/27/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,12MM02122,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Male, ,3/13/2018,9/27/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L490,9/27/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,21CM14901,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male, ,7/19/2021, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L491,9/28/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,15em05463,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male, ,3/13/2018,9/28/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L492,10/7/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19gm04476,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),63,Female, ,9/30/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L493,10/7/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,21cm14907,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,5/6/2021,10/7/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L494,10/22/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,21fm18682,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male, ,8/12/2021, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L495,11/3/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,19cm08054,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,10/20/2021, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L496,11/4/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,13EM09267,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,5/2/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L497,11/8/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,19jm01111,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),77,Female, ,2/28/2020,11/8/2021,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L498,11/10/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG +4 XLPE ACET LNR 36MM X 60MM,71338560,20DM13139,71338560, ,03596010598752,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Male, ,10/20/2021,11/10/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L499,11/11/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,21FM13340,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female, ,10/25/2021,11/11/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L500,11/24/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,17mm02589,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Female,77,4/24/2018, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L501,11/24/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,19MM15245,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip,56,Female, ,11/20/2021,11/24/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L502,12/2/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,17CM08211,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,6/24/2017, ,E161201;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L503,12/17/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,17am04057,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male,95,6/2/2017,12/17/2021,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L504,12/20/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,11HM17260,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female,85,2/15/2012,12/20/2021,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L505,12/20/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,18FM11313,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,10/31/2018,12/20/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L506,12/20/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,19DM21040,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Male, ,5/24/2021, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L507,12/21/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,16CM18882,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male, ,11/20/2017,12/21/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L508,12/22/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,21FM01756,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female, ,9/21/2021,12/22/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L509,12/30/2021,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,19jm06572,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male, ,12/16/2021, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L510,1/4/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,21gm09746,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),76,Female,63,12/18/2021, ,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L511,1/25/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,18CM00180,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,43,Male,76,11/2/2018,1/25/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L512,1/26/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19GM14691,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),74,Female, ,7/26/2021,1/26/2022,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L513,1/27/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,18GM17224,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),78,Male, ,11/19/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L514,1/27/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,21GM03112,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),55,Male,84,10/28/2021,1/27/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L515,2/7/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15JM15986,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,5/12/2016,2/7/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L516,2/10/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,13FM07502,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,90,Female, ,11/26/2013,2/10/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L517,2/16/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,20DM00945,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Male, ,3/16/2021, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L518,2/17/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15GM07076,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,12/15/2015,2/17/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L519,2/19/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,21fm14304,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Head/Socket Mismatch - Socket and Head/Socket Mismatch - Head.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Male,22,11/13/2021,2/19/2022,E2401,F1905,A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L520,3/15/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,19KM05544,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,49,Male, ,3/27/2021,3/15/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L521,3/24/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,13fm07502,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,10/21/2013,3/24/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L522,3/26/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,19hm06466,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,54,Male, ,2/16/2022, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L523,4/5/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,18EM16874,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Male, ,8/23/2018,4/5/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L524,4/21/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,21km12753,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,1/18/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L525,4/22/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,21HM06510,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),70,Female, ,4/17/2022, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L526,4/25/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16BM12361,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),89,Female, ,7/1/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L527,4/27/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,15FM12364,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,2/13/2016, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L528,4/27/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,20EM09142,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male, ,12/7/2021,4/27/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L529,5/3/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,12HM04349,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,90,Female, ,12/4/2012,5/3/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L530,5/8/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,21HM18160,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,5/5/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L531,5/10/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14fm19930,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,1/16/2015,5/10/2022,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L532,5/10/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,21FM22691,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female,45,2/25/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L533,5/11/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,19HM02602,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,4/19/2022,5/11/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L534,5/18/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16dm21560,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,4/21/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L535,5/25/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,15BM09553,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Male,87,4/11/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L536,5/26/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,21MM14654,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,44,Female, ,5/12/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L537,5/28/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,10MM09734,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female,52,1/31/2011,5/28/2022,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L538,6/6/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,14gm04345,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Male, ,12/2/2015,6/6/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L539,6/9/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,18MM00633,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,3/13/2019,6/9/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L540,6/22/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,22AM03692,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male, ,5/17/2022,6/22/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L541,6/22/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,22CM16406,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Male, ,6/16/2022, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L542,6/27/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18hm19763,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),84,Female, ,9/21/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L543,6/29/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,18MM01542,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,5/24/2019, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L544,7/14/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,19em08093,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,4/12/2022,7/14/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L545,7/19/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,18DM03356,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,4/17/2019,7/19/2022,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L546,7/19/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,19dm21060,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,74,Female, ,2/1/2021,7/19/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L547,7/20/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,16KM05483,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Failed Hemiarthroplasty,51,Female, ,7/7/2022,7/20/2022,E1614;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L548,7/29/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,22AM,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,49,Female, ,7/15/2022,7/29/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L549,8/2/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,17GM11130,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),71,Male, ,4/2/2022, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L550,8/10/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,20cm23758,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female,73,9/15/2021, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L551,8/17/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,13EM04397,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male, ,8/1/2022,8/17/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L552,8/18/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,22cm05930,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,47,Male, ,6/22/2022,8/18/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L553,8/24/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22dm19832,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Male, ,8/16/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L554,8/28/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,22dm19998,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Female,102,8/15/2022,8/28/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L555,9/1/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,11JM03764,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Female, ,11/20/2014,9/1/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L556,9/5/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE LNR 40MM ID X 56OD,71338687,13amo2682,71338687, ,00885556113189,K093363, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Male, ,6/29/2013, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L557,9/5/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 56MM,71337556,15LM05678,71337556, ,03596010615220,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,6/6/2018,9/5/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L558,9/5/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,19hm22554,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,7/16/2021,9/5/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L559,9/12/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18MM12972,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,2/4/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L560,9/12/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,22cm13376,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,69,Female, ,8/24/2022,9/12/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L561,9/13/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22DM19832,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Male,78,7/19/2022,9/13/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L562,9/14/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,9EM06524,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male, ,3/20/2014, ,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L563,9/20/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,19em19445,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,12/9/2019,9/20/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L564,9/23/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,19am20424,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,7/19/2022,9/23/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L565,10/1/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,21HM16174,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,8/1/2022,10/1/2022,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L566,10/6/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,21JM08043,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Metastatic Cancer/Malignancy,55,Male, ,12/3/2021, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L567,10/10/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,22bm04194,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,9/6/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L568,10/12/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,16KM04499,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,60,Male, ,2/2/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L569,10/12/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,21DM02622,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,61,Female, ,7/14/2022, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L570,10/14/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,22cm12977,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Female, ,8/24/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L571,10/18/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,16KM12896,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,5/8/2018,10/18/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L572,10/20/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,21CM22077,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female,107,9/19/2022,10/20/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L573,11/17/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,19GM02818,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),76,Female, ,6/24/2021, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L574,11/21/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,19gm24219,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,11/16/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L575,11/23/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,11KM00425,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female, ,5/23/2012,11/23/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L576,11/28/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,21dm08847,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Female,103,7/20/2021,11/28/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L577,11/28/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,21MM14096,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,10/10/2022,11/28/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L578,12/2/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,22HM21359,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,76,Female, ,11/20/2022, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L579,12/5/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,16JM17502,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Male, ,6/10/2017,12/5/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L580,12/25/2022,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,16cm02703,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Female, ,8/31/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L581,1/3/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG +4 XLPE ACET LNR 32MM X 54MM,71337954,18DM04504,71337954, ,03596010598660,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,3/24/2021,1/3/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L582,1/8/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,21HM12012,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Male, ,3/8/2022, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L583,1/9/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,19KM11356,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis; Previous Hip Surgery - Non Trauma Related,46,Female, ,5/10/2021,1/9/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L584,1/10/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,12am06806,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,1/3/2013,1/10/2023,E1614,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L585,1/16/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,14DM14669,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Failed Hemiarthroplasty,82,Male, ,2/13/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L586,1/16/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,18MM02084,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female,67,3/28/2019,1/16/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L587,1/26/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,12bm17138,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Female, ,5/10/2013,1/26/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L588,2/1/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,22cm12981,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female, ,11/5/2022,2/1/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L589,2/3/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,22h,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other,84,Female, ,1/19/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L590,2/6/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,22hm19357,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),67,Female, ,12/28/2022,2/6/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L591,2/8/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,12AM17982,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female, ,7/16/2013,2/8/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L592,2/8/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,14gm06339,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Chronic,76,Male, ,3/27/2018, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L593,2/10/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,13KM10557,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male, ,10/21/2015,2/10/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L594,2/13/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,22j,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,2/1/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L595,2/16/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,17EM23198,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Female, ,9/22/2017,2/16/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L596,2/17/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,11BM11352,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,94,Female, ,6/24/2011, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L597,2/20/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,22lm02869,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Female, ,2/15/2023,2/20/2023,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L598,2/22/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,21mm14606,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Male,75,4/8/2022,2/22/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L599,2/28/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,16AM09586,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,8/18/2016,2/28/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L600,3/2/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,12KM06805,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,5/9/2014,3/2/2023,E1614;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L601,3/4/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,19lm15736,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,2/12/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L602,3/6/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,19FM16580,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male,86,10/19/2020, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L603,3/9/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,17GM01137,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,3/26/2018, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L604,3/15/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,21MM02518,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem and Lysis ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female,113,3/19/2022,3/15/2023,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L605,3/21/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,19DM05079,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,8/13/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L606,3/29/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,22jm15174,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,2/13/2023,3/29/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L607,3/30/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,17am04057,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,6/7/2018, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L608,3/31/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22dwm04462,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Female, ,3/22/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L609,4/3/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,60,Female, ,12/16/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L610,4/4/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,08BM16857,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Male, ,3/31/2009,4/4/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L611,4/5/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,22hm19372,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,11/14/2022,4/5/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L612,4/5/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,22mm01494,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female, ,3/22/2023,4/5/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L613,4/12/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,15gm05358,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,10/15/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L614,4/12/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19JM05526,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female,49,10/19/2020, ,E161201;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L615,4/19/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,19GM25156,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,10/7/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L616,4/19/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22DM04462,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,3/29/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L617,4/21/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,22MM03830,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,3/24/2023, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L618,4/25/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,14dm07817,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis; Other,54,Male, ,10/21/2014,4/25/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L619,4/25/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,22mm01494,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,3/25/2023,4/25/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L620,4/26/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,19jm23845,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Female, ,8/3/2021, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L621,4/28/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,16HM05505,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Male, ,5/22/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L622,5/1/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22LM00188,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Head/Socket Mismatch - Head.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Male, ,4/22/2023, ,E1614,F1905,A24;A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L623,5/3/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 62MM,71332762,13dm01420,71332762, ,03596010598035,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Male, ,2/20/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L624,5/9/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 22MM X 44MM,71334944,19JM23844,71334944, ,03596010598080,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female, ,1/31/2022,5/9/2023,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L625,5/9/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG +4 XLPE ACET LNR 36MM X 56MM,71338556,22jm14237,71338556, ,03596010598738,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Male, ,4/22/2023,5/9/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L626,5/20/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,21AM07122,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,36,Male, ,5/24/2021,5/20/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L627,5/21/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,22JM12596,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,5/3/2023,5/21/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L628,5/22/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,21lm04584,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,5/23/2022,5/22/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L629,5/24/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,21HM14971,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male, ,4/29/2023,5/24/2023,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L630,5/24/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,23bm05198,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Male, ,5/18/2023, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L631,6/6/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,18GM00793,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),82,Female, ,11/2/2018,6/6/2023,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L632,6/14/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16EM21255,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,11/4/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L633,6/16/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,23AM15869,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,49,Female, ,5/11/2023,6/16/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L634,6/20/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 54MM,71337554,18jm05457,71337554, ,03596010615213,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Male, ,5/8/2019,6/20/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L635,6/20/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,20FM15346,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female, ,12/1/2020,6/20/2023,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L636,7/4/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,22MM05262,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Male, ,5/22/2023,7/4/2023,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L637,7/5/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,22KM15591,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female,74,7/3/2023,7/5/2023,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L638,7/19/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,21DM04851,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain and Leg Length Discrepancy.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,7/30/2021,7/19/2023,E2330;E1634,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L639,7/19/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,14dm01613,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male, ,1/18/2023, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L640,7/21/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,12FM02726,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Female, ,1/17/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L641,8/1/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23CM00302,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Female, ,6/28/2023, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L642,8/15/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,19fm12556,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip,45,Female, ,12/18/2019,8/15/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L643,8/16/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,23dm04096,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Male,86,6/26/2023,8/16/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L644,8/16/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,22hm21400,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,7/18/2023,8/16/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L645,8/22/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,15JM06259,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem and Unexplained Pain and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male, ,1/12/2016,8/22/2023,E1627;E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L646,8/28/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16DM15695,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female, ,7/26/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L647,8/29/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15EM16562,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female,74,9/1/2015,8/29/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L648,9/2/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23CM00199,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female,80,8/2/2023,9/2/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L649,9/11/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23CM12374,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male, ,8/23/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L650,9/12/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,23bm06995,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Male, ,7/7/2023,9/12/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L651,9/19/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23dm11303,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection and Implant Fracture of a ceramic component - Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,9/12/2023, ,E1906,F1905,A24;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L652,9/19/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23em14188,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,9/13/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L653,9/19/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,22KM17031,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male,91,9/18/2023,9/19/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L654,9/22/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23cm00199,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,63,Female,76,7/31/2023,9/22/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L655,9/22/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,23DM11315,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Female, ,8/19/2023,9/22/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L656,9/26/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23DM05823,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Female, ,7/9/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L657,10/5/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE LNR 40MM ID X 58OD,71338688,4MM16167,71338688, ,00885556113172,K093363, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,7/17/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L658,10/12/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,13mm02807,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Male, ,3/6/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L659,10/12/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,22MM01467,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,4/19/2023,10/12/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L660,10/13/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,23am16604,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Female, ,9/8/2023,10/13/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L661,10/20/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23cm00302,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Female,76,6/6/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L662,10/24/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,20lm06712,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Head/Socket Mismatch - Socket and Head/Socket Mismatch - Head.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female, ,10/23/2023,10/24/2023,E2401,F1905,A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L663,11/1/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14hm18427,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Female,93,5/13/2015,11/1/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L664,11/6/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,22CM21892,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,46,Female,107,9/7/2022,11/6/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L665,11/8/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,22MM13336,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male,88,10/17/2023,11/8/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L666,11/11/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,18JM11937,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,2/8/2019,11/11/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L667,11/16/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,22MM03823,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Female, ,7/24/2023,11/16/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L668,11/23/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,22KM04027,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Male, ,2/21/2023,11/23/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L669,11/24/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,23CM14834,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Male, ,10/28/2023,11/24/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L670,12/4/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,19BM10674,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,6/10/2019,12/4/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L671,12/6/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,23am07243,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,11/1/2023,12/6/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L672,12/7/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,21gm12978,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy; Osteoarthritis,64,Female,71,10/8/2021,12/7/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L673,12/11/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,23DM05829,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,60,Female,61,10/11/2023,12/11/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L674,12/19/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,23dm13228,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female,82,11/21/2023,12/19/2023,E2308;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L675,12/23/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,23EM02658,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,11/20/2023,12/23/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L676,12/26/2023,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,23HM04403,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Male, ,11/14/2023,12/26/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L677,1/3/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14JM06811,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female, ,12/8/2014, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L678,1/3/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22BM03152,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,77,Female, ,6/15/2022,1/3/2024,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L679,1/17/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,23JM16522,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female, ,12/20/2023,1/17/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L680,1/19/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,23HM17213,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Other,78,Male, ,1/11/2024,1/19/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L681,1/22/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,12bm04843,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Male, ,7/18/2012,1/22/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L682,1/25/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,13DM02510,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,10/12/2022,1/25/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L683,1/26/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16JM07491,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female, ,2/21/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L684,1/30/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,16jm00897,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Female, ,3/21/2017,1/30/2024,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L685,2/1/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,15DM00589,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,6/17/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L686,2/3/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23LM12388,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Female, ,1/26/2024, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L687,2/9/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,19FM00875,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,1/24/2020,2/9/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L688,2/11/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,23DM08428,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,63,Female, ,1/16/2024,2/11/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L689,2/12/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,22DM16755,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Congenital Dislocation/Dysplasia of the Hip,93,Female, ,11/13/2023,2/12/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L690,2/15/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,22cm05920,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female,93,10/27/2023, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L691,2/16/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16KM08968,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,53,Female, ,12/5/2017,2/16/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L692,2/19/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,20KM09187,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female,79,9/26/2022,2/19/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L693,2/19/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23FM00753,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female,98,1/18/2024,2/19/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L694,2/20/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,23DM13228,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture of a non¿ceramic component - Stem and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Female, ,2/6/2024, ,E2127,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L695,2/28/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,23GM13641,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma Acute - hip fracture,85,Female, ,2/26/2024, ,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L696,3/5/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,13mm14143,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,63,Male, ,1/21/2015,3/5/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L697,3/6/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23CM04389,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,2/27/2024, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L698,3/10/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,21dm07067,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture of a non¿ceramic component - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Male, ,2/20/2024, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L699,3/11/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19cm08592,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Female,61,5/14/2019,3/11/2024,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L700,3/25/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,23JM09036,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male, ,3/18/2024,3/25/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L701,3/28/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,19EM19882,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,8/16/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L702,3/28/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,23KM01679,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,2/9/2024,3/28/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L703,3/29/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22DM19870,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male, ,7/24/2022,3/29/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L704,4/1/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,11LM03079,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female, ,2/21/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L705,4/1/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,13cm01379,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy; Osteoarthritis,57,Female, ,7/30/2013,4/1/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L706,4/11/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,13GM03572,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,8/5/2019, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L707,4/15/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 62MM,71337662,19CM10233,71337662, ,03596010598547,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Male,91,11/29/2021,4/15/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L708,4/19/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,22em11456,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,11/5/2022,4/19/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L709,4/19/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24bm01224,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,4/16/2024,4/19/2024,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L710,4/22/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,20cm09232,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Loosening - socket and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male,92,11/24/2020, ,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L711,4/22/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23km1788,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,4/16/2024,4/22/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L712,4/25/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,22MM13364,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,3/14/2024,4/25/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L713,4/27/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,20MM03007,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male,92,7/1/2021,4/27/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L714,4/30/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,18am23776,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,52,Female, ,5/29/2018,4/30/2024,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L715,5/1/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,23EM05055,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Female, ,9/13/2023,5/1/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L716,5/14/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 62MM,71332762,22BM0206,71332762, ,03596010598035,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male, ,9/19/2023, ,E161201;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L717,5/16/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,23bm08424,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male, ,7/7/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L718,5/21/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,23bm07013,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,69,Male, ,8/2/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L719,5/23/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,21EM02767,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male,88,7/3/2021,5/23/2024,E1614,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L720,5/24/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,17gm06360,71339548, ,03596010598790,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Wear of Acetabular Component and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Female, ,1/3/2018,5/24/2024,E1614;E040203,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L721,5/28/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 50MM,71337550,18dm21945,71337550, ,03596010615190,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,7/17/2019,5/28/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L722,5/29/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19MM17249,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Leg Length Discrepancy and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,10/12/2020,5/29/2024,E2308;E1634;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L723,5/29/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,23fm06986,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,60,Female, ,5/28/2024,5/29/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L724,5/30/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,18DM09257,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,63,Male, ,12/14/2018,5/30/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L725,5/30/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,19hm02207,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,90,Male, ,10/14/2019,5/30/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L726,5/31/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23KM17894,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,3/26/2024,5/31/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L727,6/7/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,15GM08959,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,11/14/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L728,6/7/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,20am14941,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Leg Length Discrepancy.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,55,Male, ,7/13/2020, ,E1634,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L729,6/14/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14JM06806,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,4/14/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L730,6/17/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,19EM26242,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Female, ,4/27/2022,6/17/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L731,6/18/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,17CM01832,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Female,65,11/8/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L732,6/18/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,21GM14443,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male, ,12/13/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L733,6/21/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23JM05229,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Male, ,1/17/2024,6/21/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L734,6/21/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,23mm08114,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,54,Female, ,6/20/2024, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L735,6/24/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,23KM13398,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,43,Female, ,6/12/2024, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L736,6/25/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,23JM03288,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,46,Female, ,5/22/2024,6/25/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L737,6/27/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,16GM13285,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),77,Female, ,10/27/2016,6/27/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L738,6/29/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22jm21161,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Male, ,4/24/2024,6/29/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L739,7/1/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,13AM13302,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,6/11/2013, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L740,7/1/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,23jm03284,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma Acute - hip fracture,77,Female,58,6/19/2024,7/1/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L741,7/3/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19KM05646,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Female, ,1/28/2020,7/3/2024,E1906;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L742,7/3/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23MM02728,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female, ,6/11/2024,7/3/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L743,7/3/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24AM04321,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Male, ,6/26/2024,7/3/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L744,7/5/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23EM00575,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Male, ,9/9/2023, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L745,7/9/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,23EM05029,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),40,Male, ,9/25/2023,7/9/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L746,7/11/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,24BM01234,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male, ,7/4/2024,7/11/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L747,7/12/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,15LM18877,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female, ,10/12/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L748,7/15/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,22LM00188,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Male, ,3/6/2023, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L749,7/17/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,16fm13249,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Leg Length Discrepancy.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Male,105,11/6/2018, ,E1634,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L750,7/18/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,16cm09777,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Female, ,9/8/2016,7/18/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L751,7/26/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23bm10664,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,49,Male, ,9/22/2023,7/26/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L752,7/30/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23m00323,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,76,Male, ,6/9/2023,7/30/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L753,8/5/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,23cm07831,71339550, ,03596010598806,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,53,Female, ,4/29/2024,8/5/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L754,8/6/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,23hm05025,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Male, ,5/13/2024, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L755,8/7/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23KM03556,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,59,Male, ,6/8/2024,8/7/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L756,8/14/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,12CM08279,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,7/24/2013,8/14/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L757,8/14/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,15MM10771,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,9/9/2016,8/14/2024,E1614;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L758,8/14/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,21GM00255,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Male, ,2/25/2022,8/14/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L759,8/22/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,14GM04345,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Male, ,1/20/2015,8/22/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L760,8/28/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,13HM04214,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Leg Length Discrepancy and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female, ,11/19/2013,8/28/2024,E1634;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L761,8/30/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,23MM06408,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,60,Female, ,7/25/2024,8/30/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L762,9/9/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,15AM03692,71334946, ,03596010598097,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,64,Female,59,1/26/2016,9/9/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L763,9/10/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,24CM00376,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN); Osteoarthritis,53,Male, ,8/19/2024,9/10/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L764,9/11/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24BM08125,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Male, ,8/31/2024, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L765,9/17/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24BM08120,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,91,Male, ,8/14/2024,9/17/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L766,9/21/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24DM13336,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Male,80,8/13/2024,9/21/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L767,9/21/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24DM13526,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Male, ,9/6/2024,9/21/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L768,9/25/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,19mm04414,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female, ,7/29/2020,9/25/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L769,9/25/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24CM07675,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female,54,7/17/2024, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L770,9/26/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,24AM05872,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy,58,Female,106,6/3/2024, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L771,10/2/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,11AM08599,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,9/7/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L772,10/7/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,23KM17886,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male, ,7/27/2024, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L773,10/8/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,23hm11437,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy; Osteoarthritis,89,Male, ,5/29/2024,10/8/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L774,10/16/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24DM13529,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,9/9/2024,10/16/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L775,10/24/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,20EM12643,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,7/27/2022,10/24/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L776,10/28/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,24AM12259,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Male, ,9/27/2024,10/28/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L777,11/8/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,20AM15486,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),63,Female,89,8/11/2021,11/8/2024,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L778,11/12/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEGREE XLPE LNR 32MM X 54MM,71339554,16cm00617,71339554, ,03596010583093,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,36,Female, ,5/26/2017,11/12/2024,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L779,11/12/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,20km05221,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Male, ,5/28/2021,11/12/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L780,11/15/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,19BM10793,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,57,Female, ,7/15/2019,11/15/2024,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L781,11/16/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,19GM20320,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Male, ,11/13/2024,11/16/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L782,11/18/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 28MM X 50MM,71337550,07gm,71337550, ,03596010615190,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Implant Fracture of a ceramic component - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female, ,11/19/2010, ,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L783,11/20/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,24EM07902,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Lysis ¿ Stem and Lysis ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,70,Female, ,11/4/2024, ,E1627;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L784,11/21/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24DM16921,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other Inflammatory Arthropathy; Osteoarthritis,58,Male, ,10/22/2024,11/21/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L785,11/29/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24DM13336,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Unexplained Pain and Implant Fracture of a non¿ceramic component - Stem and Implant Fracture of a non¿ceramic component - Socket and Implant Fracture of a non¿ceramic component - Head and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Male, ,11/25/2024, ,E2330;E2127,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L786,12/3/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,12fm09324,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Male,77,11/30/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L787,12/3/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,22AM19458,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Female, ,6/16/2022,12/3/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L788,12/9/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,19KM24203,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,10/23/2020,12/9/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L789,12/9/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,24DM08738,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,11/22/2024, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L790,12/11/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,16EM05946,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,82,Male, ,7/18/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L791,12/11/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,24BM06242,71332754, ,03596010597991,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male,95,7/25/2024,12/11/2024,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L792,12/12/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,24dm08735,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,65,Male, ,9/19/2024,12/12/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L793,12/16/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24DM14575,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male, ,11/21/2024, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L794,12/17/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,17JM04554,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation and Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Female, ,2/13/2018,12/17/2024,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L795,12/18/2024,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,23hm18625,71337648, ,03596010598479,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Female, ,11/18/2024,12/18/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L796,1/4/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,14gm09291,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male,111,11/8/2014,1/4/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L797,1/6/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,19lm14033,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,83,Male, ,8/26/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L798,1/8/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,19CM23854,71332752, ,03596010597984,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection and Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female,58,7/26/2019,1/8/2025,E1906,F1905,A24;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L799,1/16/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,24AM08840,71339552, ,03596010583086,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),46,Male, ,7/18/2024,1/16/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L800,1/22/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,21mm05981,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,62,Female, ,3/3/2022,1/22/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L801,2/4/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,24DM08755,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Female, ,1/8/2025, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L802,2/6/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24HL00481,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Male, ,1/3/2025,2/6/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L803,2/12/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24EM06087,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Chronic,70,Female, ,12/4/2024, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L804,2/19/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,14GM04338,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,67,Male,76,3/10/2015,2/19/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L805,2/20/2025,5/25/2025,4/10/2025,R3 XLPE Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,24hl00493,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixty-five thousand three hundred and twenty-nine (65,329) hips underwent primary THA procedures between 24-Apr-2008 and 26-Feb-2025, using an R3 XLPE liner. From these, eight hundred and five (805) hips were later revised due to the following complications: dislocation/subluxation (241), infection (190), periprosthetic fracture (222), aseptic loosening (63), implant malalignment (62), pain (27), other-unspecified reasons (39), adverse soft tissue reaction to particle debris (17), wear of acetabular component (13), implant fracture (18), osteolysis (12), dissociation of liner (5), unequal limb length (5) and implant mismatch (6).;Timeframe of Registry data: Implantations conducted between 24-Apr-2008 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-five thousand three hundred and twenty-nine (65,329) primary THA procedures with R3 XLPE inserts have been performed in the United Kingdom between 24-Apr-2008 and 26-Feb-2025. The mean cumulative revision rates for the R3 XLPE inserts were in line with the mean cumulative revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 0.73% (0.66%-0.80%) vs 0.79% (0.78%-0.81%) of the class.;o At 3rd postoperative year: 1.05% (0.96%-1.13%) vs 1.42% (1.40%-1.44%) of the class.;o At 5th postoperative year: 1.30% (1.20%-1.40%) vs 2.0% (1.97%-2.02%) of the class.;o At 10th postoperative year: 1.94% (1.78%-2.12%) vs 3.74% (3.70%-3.78%) of the class.;o At 15th postoperative year: 2.99% (2.21%-4.04%) vs 6.02% (5.95%-6.09%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,56,Male, ,1/25/2025, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L1,5/14/2009,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 58MM,71334958,08CM01380,71334958, ,03596010598158,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Loosening - socket, Lysis ¿ Stem, Lysis ¿ Socket, Malalignment ¿ Socket, Unexplained Pain",53,Female,58,1/14/2009, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L2,7/29/2013,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG +4 XLPE ACET LNR 32MM X 60MM,71337960,07LM11242,71337960, ,03596010598691,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dislocation/Subluxation,71,Male,80,2/25/2009, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L3,10/6/2010,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,08CM06573,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,79,Female, ,7/20/2009, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L4,1/6/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,08FM0511,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening ¿ stem and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening - socket,77,Male, ,7/23/2009, ,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L5,6/21/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,111,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,40,Male, ,9/4/2009, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L6,7/22/2011,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,08BM12594,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening - socket, Unexplained Pain, Wear of Acetabular Component",55,Female,59,9/24/2009, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L7,1/26/2010,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,09CM01126,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening - socket,72,Female, ,11/10/2009, ,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L8,11/25/2010,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 50MM,71334950,09EM03540,71334950, ,03596010598110,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening ¿ stem and Infection and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,34,Female,58,3/10/2010,11/25/2010,E161201;E1906;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L9,5/24/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,1245,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Other,86,Male, ,3/16/2010, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L10,2/15/2011,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,08LM05142,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Wear of Acetabular Component",76,Female,65,3/30/2010,2/15/2011,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L11,6/11/2010,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,08CM04054,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Loosening - socket",77,Male,70,5/14/2010, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L12,1/31/2011,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,07LM08244,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Other (please specify), EFFUSION",49,Female, ,1/4/2011, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L13,7/12/2022,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,0CM00274,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dissociation of liner,79,Female, ,1/13/2011,7/12/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L14,12/15/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,08gm18046,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Other",77,Male, ,4/15/2011, ,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L15,8/12/2014,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,08KM00137,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Peri-Prosthetic Fracture ¿ Stem, Other, Adverse Soft Tissue Reaction to Particulate Debris",65,Male,90,7/7/2011, ,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L16,7/13/2012,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,08MM17091,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,78,Male, ,7/29/2011, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L17,8/22/2013,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,07mm07062,71332760, ,03596010598028,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Unexplained Pain and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,78,Male,81,8/4/2011, ,E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L18,9/14/2018,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,10MM09734,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dislocation/Subluxation,74,Female, ,8/19/2011,9/14/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L19,2/25/2014,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,10k,71335752, ,03596010598332,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Other,79,Female, ,9/13/2011, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L20,10/21/2024,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 66/68MM,71335766,08bm24453,71335766, ,03596010598400,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,58,Male, ,1/4/2012,10/21/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L21,6/25/2013,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,11em06,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dislocation/Subluxation,77,Female, ,1/10/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L22,5/23/2012,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,11hm17576,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Unexplained Pain, Other",64,Female, ,2/1/2012, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L23,2/7/2013,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,11cm06209,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Unexplained Pain",72,Male, ,2/2/2012, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L24,6/23/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 32MM X 60MM,71339560,08cm06581,71339560, ,03596010615275,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,64,Female, ,4/3/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L25,8/21/2013,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,11HM10344,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Peri-Prosthetic Fracture ¿ Socket,67,Female, ,8/21/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L26,10/23/2012,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,11JM02738,71339556, ,03596010615251,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dislocation/Subluxation,71,Female, ,8/22/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L27,3/12/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 60MM,71334960,08GM12802,71334960, ,03596010598172,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Lysis ¿ Stem, Lysis ¿ Socket, Unexplained Pain",68,Female,62,11/22/2012, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L28,8/7/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,12DM13726,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening - socket, Unexplained Pain",78,Female, ,2/14/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L29,1/14/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG +4 XLPE ACET LNR 36MM X 52MM,71338552,8KM16709,71338552, ,03596010598714,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Malalignment ¿ Socket, Peri-Prosthetic Fracture ¿ Socket",74,Female,60,11/14/2013, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L30,10/6/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14AM17326,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Lysis ¿ Stem, Lysis ¿ Socket, Other",59,Female,91,5/15/2014, ,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L31,7/2/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,13HM04214,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Dislocation/Subluxation, Wear of Acetabular Component",70,Female,78,6/19/2014, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L32,8/28/2014,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,11EM05139,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening - socket, Lysis ¿ Socket, Unexplained Pain",79,Male, ,7/17/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L33,2/19/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 60MM,71334960,05986I0,71334960, ,03596010598172,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening - socket, Lysis ¿ Socket, Unexplained Pain",65,Male,92,9/11/2014, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L34,12/1/2017,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,12bm18329,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Other,71,Male,73,10/14/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L35,11/18/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,13CM16445,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Unexplained Pain and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,64,Female, ,11/18/2014, ,E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L36,3/5/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14HM18427,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Implant Fracture - stem,64,Female, ,2/19/2015, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L37,7/16/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,13MM16432,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Lysis ¿ Socket,70,Female, ,2/26/2015, ,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L38,10/13/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,15CM03229,71332758, ,03596010598011,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,76,Female, ,6/26/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L39,11/9/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,08jm09187,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Peri-Prosthetic Fracture ¿ Stem,43,Male,116,7/7/2015, ,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L40,4/21/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,12mm03759,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Lysis ¿ Stem and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Lysis ¿ Stem, Infection",72,Male, ,7/30/2015, ,E1627;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L41,11/2/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,14km01741,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,46,Female,63,9/8/2015, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L42,8/24/2022,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,12MM09668,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Peri-Prosthetic Fracture ¿ Socket,76,Female, ,10/15/2015,8/24/2022,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L43,11/26/2015,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,15gm03884,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Unexplained Pain",71,Female, ,10/15/2015, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L44,10/20/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 52MM,71334952,15am15036,71334952, ,03596010598127,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening - socket,67,Female,60,10/22/2015, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L45,9/1/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,07JM15916,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,82,Male, ,12/13/2015, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L46,9/24/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,15HM19944,71334954, ,03596010598134,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,79,Female,74,1/19/2016,9/24/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L47,8/13/2020,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,14AM02161,71332756, ,03596010598004,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,65,Female, ,2/5/2016,8/13/2020,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L48,7/13/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,15KM16834,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Lysis ¿ Socket, Malalignment ¿ Stem, Adverse Soft Tissue Reaction to Particulate Debris",69,Female,76,5/4/2016, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L49,4/5/2017,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,14am18104,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Peri-Prosthetic Fracture ¿ Stem,65,Female,93,5/5/2016, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L50,7/25/2016,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,14JM03297,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Loosening - socket",77,Female, ,6/28/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L51,5/4/2017,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,10DM09629,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Loosening - socket",72,Male,98,7/18/2016, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L52,4/1/2017,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,16hm11768,71335760, ,03596010598370,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,73,Female,58,2/28/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L53,7/21/2020,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,16CM18959,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Unexplained Pain and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Unexplained Pain,72,Male, ,5/18/2017,7/21/2020,E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L54,6/29/2017,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,14KM01739,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening - socket,66,Male,90,6/26/2017, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L55,8/14/2017,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,16fm15227,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,71,Male, ,6/26/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L56,4/30/2018,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 64MM,71335764,17dm05974,71335764, ,03596010598394,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,63,Female,100,11/13/2017, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L57,3/22/2018,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,14GM2027,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dissociation of liner,74,Female, ,12/7/2017, ,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L58,1/7/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 28MM X 56MM,71334956,16jm15101,71334956, ,03596010598141,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,52,Male,81,12/7/2017,1/7/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L59,8/14/2024,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,17gm15216,71335754, ,03596010598349,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,66,Female, ,1/26/2018,8/14/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L60,10/30/2023,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,17LM04698,71337652, ,03596010598493,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Dislocation/Subluxation, Wear of Acetabular Component, Adverse Soft Tissue Reaction to Particulate Debris",46,Female,54,1/29/2018,10/30/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L61,9/27/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,17jm03193,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Unexplained Pain,68,Female,76,5/24/2018,9/27/2019,E161201;E040203,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L62,8/29/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,14jm11820,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,66,Female, ,7/3/2018,8/29/2019,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L63,1/9/2021,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG +4 XLPE ACET LNR 36MM X 56MM,71338556,17AM18086,71338556, ,03596010598738,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,71,Male, ,8/7/2018,1/9/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L64,6/18/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,18DM17778,71337658, ,03596010598523,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,56,Female,107,8/14/2018,6/18/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L65,12/31/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,18jm00166,71337656, ,03596010598516,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Unexplained Pain,67,Female,74,11/20/2018,12/31/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L66,11/23/2018,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,17em12739,71337650, ,03596010598486,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dislocation/Subluxation,76,Female, ,11/23/2018,11/23/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L67,5/25/2020,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,18hm22787,71337654, ,03596010598509,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Peri-Prosthetic Fracture ¿ Stem,71,Female, ,11/29/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L68,11/16/2020,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,16DM15522,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,67,Female, ,12/18/2018,11/16/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L69,11/22/2022,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 62MM,71337662,18dm05022,71337662, ,03596010598547,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening - socket,80,Female, ,1/17/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L70,8/27/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG +4 XLPE ACET LNR 36MM X 56MM,71338556,18hm03588,71338556, ,03596010598738,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dislocation/Subluxation,69,Female, ,6/25/2019,8/27/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L71,10/8/2020,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 60MM,71337660,18dm17786,71337660, ,03596010598530,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening - socket,72,Female, ,7/18/2019,10/8/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L72,11/18/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 32MM X 62MM,71337662,18gm14277,71337662, ,03596010598547,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening ¿ stem, Loosening - socket",75,Male, ,8/15/2019, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L73,9/17/2019,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 0 DEG XLPE ACET LNR 36MM X 64MM,71332764,11LM10968,71332764, ,03596010598042,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Loosening - socket, Lysis ¿ Socket",71,Male, ,9/17/2019,9/17/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L74,9/24/2021,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,16hm05986,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening - socket,74,Female, ,9/16/2020, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L75,8/2/2022,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,21FM08101,71335756, ,03596010598356,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Unexplained Pain,51,Male,94,8/9/2021, ,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L76,4/20/2022,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,21gm12977,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Dislocation/Subluxation,80,Male, ,9/3/2021,4/20/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L77,3/14/2022,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,21EM13050,71335762, ,03596010598387,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Adverse Soft Tissue Reaction to Particulate Debris,61,Male, ,12/22/2021,3/14/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L78,12/15/2023,10/23/2025,4/10/2025,R3 XLPE Acetabular Insert,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,23CM14834,71335758, ,03596010598363,K113848, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 7-Feb-2025, using an R3 XLPE Acetabular insert. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eight hundred ninety-eight (898) hips underwent revision THA procedures between 10-Sep-2008 and 07-Feb-2025, using an R3 XLPE Acetabular insert. From these, seventy-eight (78) hips were later re-revised due to the following complications: dislocation/subluxation (19), infection (17), aseptic loosening (21), periprosthetic fracture (12), pain (10), adverse soft tissue reaction to particle debris (6), malalignment of implant (2), wear of acetabular component (2), other-unknown reasons (2) and osteolysis associated with the femoral stem (1). It should be noted that more than one reason for revision may be listed for each revision surgery. ;;Timeframe of Registry data: Implantations conducted between 10-Sep-2008 and 07-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eight hundred ninety-eight (898) revision THA procedures with R3 XLPE acetabular inserts have been performed in the United Kingdom between 10-Sep-2008 and 7-Feb-2025. The mean cumulative re-revision rates for the R3 XLPE acetabular insert were in line with the mean cumulative re-revision rates for the THA NJR class across all years of follow-up data available. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;o At 1st postoperative year: 4.76% (3.54%-6.38%) vs 5.66% (5.45%-5.88%) of the class.;o At 3rd postoperative year: 6.93% (5.42%-8.83%) vs 9.48% (9.20%-9.76%) of the class.;o At 5th postoperative year: 8.16% (6.49%-10.22%) vs 11.53% (11.22%-11.85%) of the class.;o At 10th postoperative year: 9.50% (7.62%-11.81%) vs 15.23% (14.83%-15.64%) of the class.;o At 15th postoperative year: 11.10% (8.36%-14.66%) vs 19.03% (18.31%-19.78%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening ¿ stem,58,Male, ,8/30/2023,12/15/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L1, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L2, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L3, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L4, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L5, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L6, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L7, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L8, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L9, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L10, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L11, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L12, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L13, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L14, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L15, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L16, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L17, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L18, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L19, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L20, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L21, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L22, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L23, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L24, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L25, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L26, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L27, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L28, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L29, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L30, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L31, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L32, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L33, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L34, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L35, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L36, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L37, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L38, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L39, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L40, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L41, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L42, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L43, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L44, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L45, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L46, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L47, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L48, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L49, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L50, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L51, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L52, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L53, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L54, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L55, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L56, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L57, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L58, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L59, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L60, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L61, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L62, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L63, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L64, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L65, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L66, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L67, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L68, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L69, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L70, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L71, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L72, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L73, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L74, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L75, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L76, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L77, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L78, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L79, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L80, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L81, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L82, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L83, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L84, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L85, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L86, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L87, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L88, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L89, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L90, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L91, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L92, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L93, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L94, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L95, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L96, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L97, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L98, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L99, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L100, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L101, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L102, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L103, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L104, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L105, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L106, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L107, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L108, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L109, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L110, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L111, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L112, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L113, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L114, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L115, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L116, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L117, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L118, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L119, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L120, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L121, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L122, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L123, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L124, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L125, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L126, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L127, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L128, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L129, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L130, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L131, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L132, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L133, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L134, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L135, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L136, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L137, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L138, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L139, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L140, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L141, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L142, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L143, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L144, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L145, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L146, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L147, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L148, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L149, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L150, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L151, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L152, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L153, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L154, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L155, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L156, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L157, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L158, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L159, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L160, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L161, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L162, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L163, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L164, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L165, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L166, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L167, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L168, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L169, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L170, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L171, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L172, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L173, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L174, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L175, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L176, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L177, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L178, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L179, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L180, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L181, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L182, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L183, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L184, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L185, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L186, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L187, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L188, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L189, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L190, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L191, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L192, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L193, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L194, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L195, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L196, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L197, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L198, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L199, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L200, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L201, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L202, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L203, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L204, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L205, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L206, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L207, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L208, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L209, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L210, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L211, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L212, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L213, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L214, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L215, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L216, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L217, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L218, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L219, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L220, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L221, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L222, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L223, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L224, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L225, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L226, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L227, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L228, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L229, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L230, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L231, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L232, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L233, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L234, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L235, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L236, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L237, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L238, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L239, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L240, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L241, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L242, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L243, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L244, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L245, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L246, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L247, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L248, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L249, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L250, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L251, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L252, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L253, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L254, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L255, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L256, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L257, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L258, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L259, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L260, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L261, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L262, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L263, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L264, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L265, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L266, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L267, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L268, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L269, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L270, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L271, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L272, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L273, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L274, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L275, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L276, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L277, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L278, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L279, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L280, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L281, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L282, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L283, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L284, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L285, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L286, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L287, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L288, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L289, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L290, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L291, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L292, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L293, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L294, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L295, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L296, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L297, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L298, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L299, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L300, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L301, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L302, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L303, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L304, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L305, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L306, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L307, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L308, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L309, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L310, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L311, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L312, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L313, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L314, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L315, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L316, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L317, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L318, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L319, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L320, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L321, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L322, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L323, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L324, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L325, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L326, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L327, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L328, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L329, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L330, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L331, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L332, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L333, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L334, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L335, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L336, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L337, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L338, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L339, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L340, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L341, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L342, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L343, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L344, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L345, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L346, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L347, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L348, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L349, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L350, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L351, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L352, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L353, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L354, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L355, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L356, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L357, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L358, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L359, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L360, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L361, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L362, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L363, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L364, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L365, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L366, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L367, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L368, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L369, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L370, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L371, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L372, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L373, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L374, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L375, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L376, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L377, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L378, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L379, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L380, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L381, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L382, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L383, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L384, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L385, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267331-1-L386, ,10/23/2025,4/28/2025,CPCS Stem,CPCS Stem, , , , , ,K823727, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of sixteen thousand six hundred and seventy-four (16,674) hips underwent primary THA procedures between 6-May-2003 and 31-Mar-2025, using an CPCS stem. From these, three hundred and eighty-six (386) hips were later revised due to the following reasons: twenty (20) hips due to unexplained pain, seventy-five (75) hips due to dislocation/subluxation, thirty-eight (38) hips due to adverse soft tissue reaction, fifty-three (53) hips due to infection, thirty-seven (37) hips due to aseptic loosening of the stem, ninety-four (94) hips due to aseptic loosening of the cup, one hundred and one (101) hips due to periprosthetic fracture associated with the stem, ten (10) hips due to periprosthetic fracture associated with the cup, four (4) hips due to malalignment of the stem, eighteen (18) hips due to malalignment of the socket, two (2) hips due to leg length discrepancy, thirty-seven (37) hips due to wear of the acetabular component, twenty (20) hips due to lysis associated with the stem, thirty-six (36) hips due to lysis associated with the cup, one (1) hip due to implant fracture of the ceramic head, two (2) hips due to implant fracture of the ceramic liner, two (2) hips due to implant fracture of the poly liner, four (4) hips due to dissociation of the liner, and twelve (12) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 6-May-2003 and 31-Mar-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CPCS Hip Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of sixteen thousand six hundred and seventy-four (16,674) primary THA procedures with CPCS femoral stems have been performed in the United Kingdom between 6-May-2003 and 31-Mar-2025. The mean cumulative revision rates for the CPCS femoral stems in primary THA are in line with the class though 8 years of follow-up. From 9 years onward, the mean rises above the class, being significantly higher based on non-overlapping 95% confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 0.64% (0.53%¿0.77%) vs 0.76% (0.75%¿0.77%) of the class.;;¿ At 2nd postoperative year: 0.92% (0.78%¿1.07%) vs 1.06% (1.04%¿1.07%) of the class.;;¿ At 3rd postoperative year: 1.14% (0.98%¿1.32%) vs 1.32% (1.30%¿1.34%) of the class.;;¿ At 4th postoperative year: 1.41% (1.22%¿1.61%) vs 1.57% (1.55%¿1.59%) of the class.;;¿ At 5th postoperative year: 1.76% (1.54%¿2.00%) vs 1.82% (1.80%¿1.84%) of the class.;;¿ At 6th postoperative year: 2.11% (1.85%¿2.39%) vs 2.09% (2.06%¿2.11%) of the class.;;¿ At 7th postoperative year: 2.47% (2.16%¿2.79%) vs 2.36% (2.33%¿2.38%) of the class.;;¿ At 8th postoperative year: 3.00% (2.63%¿3.39%) vs 2.65% (2.62%¿2.68%) of the class.;;¿ At 9th postoperative year: 3.45% (3.03%¿3.90%) vs 2.95% (2.92%¿2.98%) of the class.;;¿ At 10th postoperative year: 3.96% (3.48%¿4.48%) vs 3.27% (3.24%¿3.31%) of the class.;;¿ At 11th postoperative year: 4.42% (3.87%¿4.99%) vs 3.63% (3.59%¿3.67%) of the class.;;¿ At 12th postoperative year: 5.63% (4.92%¿6.40%) vs 4.03% (3.99%¿4.08%) of the class.;;¿ At 13th postoperative year: 6.31% (5.51%¿7.18%) vs 4.43% (4.38%¿4.48%) of the class.;;¿ At 14th postoperative year: 7.37% (6.41%¿8.39%) vs 4.86% (4.81%¿4.92%) of the class.;;¿ At 15th postoperative year: 8.07% (6.98%¿9.23%) vs 5.33% (5.27%¿5.39%) of the class.;;¿ At 16th postoperative year: 9.03% (7.74%¿10.55%) vs 5.83% (5.75%¿5.90%) of the class.;;¿ At 17th postoperative year: 9.86% (8.22%¿11.79%) vs 6.33% (6.25%¿6.42%) of the class.;;¿ At 18th postoperative year: 11.25% (8.89%¿13.94%) vs 6.84% (6.74%¿6.94%) of the class.;;¿ At 19th postoperative year:11.25% (8.89%¿15.21%) vs 7.32% (7.20%¿7.45%) of the class. iR;;The performance of CPCS stems was further reviewed by analyzing the articular insert used in combination with these stems. Approximately 66% of all CPCS stems have been implanted with polyethylene inserts (66%), 2% with ceramic inserts, 2% were off-label usage of inserts from other manufacturers and 30% of the cases did not report information on the manufacturer of insert utilized. Only 5 primary THAs were associated with a metal-on-metal option, which is no longer available for CPCS stems, and recorded a total of 2 revisions surgeries been performed after primary implantation. By using this stratification to analyze the Kaplan-Meier cumulative revision rates, it is concluded that the CPCS stems utilized on label with Smith & Nephew polyethylene and ceramic inserts are all performing in line with the class across all available years, as shown by overlapping of the 95% confidence intervals. With respect to the off-label usage, the CPCS stem is performing in line with the class across all available follow up years with the exception of the 5th follow up year (3.71%; 1.85%-7.38% vs 1.57%; 1.55%-1.59% of the class), as shown by overlapping of the 95% confidence intervals.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269427-1-L1,6/26/2006,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 0 DEGREE LATERALIZED +4MM 50-52MM OUTER DIAMETER SIZE E,71333484,03LM05561,71333484, ,03596010491817,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Loosening of the socket, Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Malalignment of the Socket,56,Female,,10/6/2004,6/26/2006,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L2,7/19/2012,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 0 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333386,04GM20644,71333386, ,03596010455949,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Implant Fracture of the stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Lysis of the Stem,90,Male,,10/7/2004,7/19/2012,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L3,5/2/2014,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,04FM16182,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the stem, Other, Loosening",83,Female,,12/2/2004,5/2/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L4,7/17/2006,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 62-64MM OUTER DIAMETER SIZE H,71333337,02CM04703,71333337, ,03596010455703,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Dislocation/Subluxation,74,Female,,5/25/2006,7/17/2006,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L5,1/14/2020,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,6LM01323,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Implant Fracture of the stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Unexplained Pain,71,Male,105,2/23/2007,1/14/2020,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L6,11/3/2008,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,6CM05786,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the stem, Loosening of the socket",64,Female,66,3/5/2007,11/3/2008,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L7,1/23/2024,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333396,06GM10904,71333396, ,03596010479730,K022902, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Loosening of the socket,74,Female,,3/22/2007,1/23/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L8,9/14/2009,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333325,07DM05407,71333325, ,03596010455628,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the stem, Loosening of the socket",59,Female,,9/3/2007,9/14/2009,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L9,9/30/2019,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,7FM16010,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Lysis of the Socket, Unexplained Pain, Wear of Acetabular Component",66,Male,92,9/5/2007,9/30/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L10,7/7/2008,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,7GM08769,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Loosening of the stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Malalignment of the Socket, Dislocation/Subluxation, Unexplained Pain",82,Male,77,9/18/2007,7/7/2008,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L11,11/21/2007,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,06CM04024,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Dislocation/Subluxation, Unexplained Pain",58,Female,,9/19/2007,11/21/2007,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L12,6/20/2022,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,7JM01882,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the socket, Malalignment of the Socket, Unexplained Pain, Other, Totally bare trochanter with no abducters attatche",77,Male,109,10/17/2007,6/20/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L13,7/27/2020,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,07JM13686,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Infection,60,Male,,11/26/2007,7/27/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L14,3/12/2019,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,07GM00188,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Loosening of the stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the socket, Lysis of the Socket, Unexplained Pain, Wear of Acetabular Component, Dissociation of liner",63,Female,56,11/27/2007,3/12/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L15,2/27/2008,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,07KM21310,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Dislocation/Subluxation,64,Female,,2/15/2008,2/27/2008,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L16,3/17/2021,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 62-64MM OUTER DIAMETER SIZE H,71333337,07GM01459,71333337, ,03596010455703,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the stem, Loosening of the socket, Unexplained Pain",59,Male,,3/28/2008,3/17/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L17,5/14/2008,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,07LM12678,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the stem, Loosening of the socket, Unexplained Pain",72,Female,83,4/4/2008,5/14/2008,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L18,6/17/2014,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 62-64MM OUTER DIAMETER SIZE H,71333337,07MM15505,71333337, ,03596010455703,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the stem, Lysis of the Stem, Wear of Acetabular Component",70,Male,90,7/1/2008,6/17/2014,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L19,2/9/2009,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 66-68MM OUTER DIAMETER SIZE J,71333338,07AM15054,71333338, ,03596010455710,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Infection, Unexplained Pain",78,Male,120,1/14/2009,2/9/2009,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L20,7/6/2012,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,08FM23040,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the socket, Unexplained Pain",56,Female,,1/30/2009,7/6/2012,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L21,10/28/2010,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,08JM21019,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Loosening of the stem, Implant Fracture of the stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Other, valgus",81,Male,79,2/3/2009,10/28/2010,E161201;E2401,F1905,A0102;A040101,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L22,10/19/2011,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333396,9CM08115,71333396, ,03596010479730,K022902, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Malalignment of the Socket, Dislocation/Subluxation",70,Male,81,10/14/2009,10/19/2011,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L23,2/11/2011,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,09fm05279,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Other","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Unexplained Pain,58,Female,,10/16/2009,2/11/2011,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L24,11/22/2010,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,09BM06757,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Loosening of the socket, Other","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Loosening of the stem, Loosening of the socket, Lysis of the Stem, Lysis of the Socket, Unexplained Pain",79,Male,68,11/24/2009,11/22/2010,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L25,3/28/2011,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333395,08AM18359,71333395, ,03596010479723,K022902, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of the Socket, Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Lysis of the Socket, Unexplained Pain, Adverse Soft Tissue Reaction to Particulate Debris",66,Female,,5/10/2010,3/28/2011,E2127;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L26,9/1/2017,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333345,10BM13130,71333345, ,03596010479754,K022902, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Loosening of the socket","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Unexplained Pain,78,Female,,7/23/2010,9/1/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269427-1-L27,6/2/2021,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333345,10DM15893,71333345, ,03596010479754,K022902, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of the Stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a Reflection XLPE Liner. From these, twenty-seven (27) hips were later re-revised due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to periprosthetic fracture associated with the stem. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) revision THA procedures with Reflection XLPE inserts have been performed in the United Kingdom between 06-Oct-2004 and 09-Mar-2015. The mean cumulative re-revision rates for the Reflection XLPE insert were lower than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) across all years of follow-up data available. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 4.19% (2.12%-8.20%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 7.41% (4.46%-12.19%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 7.96% (4.88%-12.87%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 8.55% (5.33%-13.59%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 10.51% (6.82%-16.03%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 15.71% (10.75%-22.64%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 16.88% (11.61%-24.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Other,78,Female,,8/13/2010,6/2/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L1,5/25/2010,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,6HM01586,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,60,Male,66,1/3/2007,5/25/2010,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L2,11/26/2007,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 0 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333374,05cm21434,71333374, ,03596010455864,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,60,Female,,1/27/2007,11/26/2007,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L3,1/7/2015,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,7AM08029,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,66,Male,110,3/28/2007,1/7/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L4,6/25/2007,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,7BM09608,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Loosening of the stem, Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,66,Female,,4/19/2007,6/25/2007,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L5,11/4/2008,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 46-48MM OUTER DIAMETER SIZE D,71333323,05GM10778,71333323, ,03596010455604,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,73,Female,,5/1/2007,11/4/2008,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L6,12/7/2020,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,7DM02683,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture of the Stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,79,Male,,9/6/2007,12/7/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L7,11/9/2011,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,7FM20227,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,62,Male,,11/25/2007,11/9/2011,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L8,9/28/2011,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,7JM08383,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,61,Male,84,12/12/2007,9/28/2011,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L9,1/6/2014,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 0 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333384,07FM05893,71333384, ,03596010455925,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,51,Female,,1/17/2008,1/6/2014,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L10,8/23/2024,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,07JMO1593,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Periprosthetic Fracture","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,86,Female,63,1/18/2008,8/23/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L11,1/19/2012,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333324,07jm19324,71333324, ,03596010455611,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Loosening of the stem, Lysis of the Stem, Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Other Inflammatory Arthropathy,73,Female,,3/14/2008,1/19/2012,E161201;E1627;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L12,2/13/2018,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333324,08am14128,71333324, ,03596010455611,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture of the Stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,65,Female,81,3/15/2008,2/13/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L13,11/11/2016,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,07FM00289,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Malalignment of the Socket, Peri-Prosthetic Fracture of the Stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Trauma - Acute (e.g. Neck Of Femur),83,Female,76,3/28/2008,11/11/2016,E2308;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L14,12/1/2018,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,08jm09241,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Malalignment of the Socket, Wear of Acetabular Component","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Other,77,Female,,2/5/2009,12/1/2018,E2308;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L15,7/26/2022,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333395,06cm17576,71333395, ,03596010479723,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Lysis of the Stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,80,Male,,2/12/2009,7/26/2022,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L16,10/16/2017,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,09DM22632,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Wear of Acetabular Component","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,53,Female,64,8/11/2009,10/16/2017,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L17,6/12/2014,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333325,08em03503,71333325, ,03596010455628,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,41,Male,,8/25/2009,6/12/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L18,7/1/2014,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333325,09cm21712,71333325, ,03596010455628,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,66,Male,,9/7/2009,7/1/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L19,2/21/2023,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 0 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333374,08KM13643,71333374, ,03596010455864,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,89,Female,,10/14/2009,2/21/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L20,12/8/2009,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334,09DM08822,71333334, ,03596010455673,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,78,Female,,11/6/2009,12/8/2009,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L21,5/29/2013,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 0 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333386,8HM02279,71333386, ,03596010455949,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,80,Male,86,11/14/2009,5/29/2013,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L22,8/10/2012,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,09HM12834A,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,71,Male,,2/12/2010,8/10/2012,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L23,5/2/2010,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,08BM07810,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture of the Stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,72,Male,,4/22/2010,5/2/2010,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L24,5/18/2011,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 0 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333384,9BM12597B,71333384, ,03596010455925,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Other","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Trauma - Chronic,66,Female,75,8/18/2010,5/18/2011,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L25,9/16/2010,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333346,0AM04208,71333346, ,03596010479761,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,84,Male,,8/25/2010,9/16/2010,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L26,7/23/2011,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333345,07GM11422,71333345, ,03596010479754,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Head/Socket Mismatch - Head","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,58,Male,83,4/12/2011,7/23/2011,E2401,F1905,A2303,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L27,4/4/2014,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335,10EM03261,71333335, ,03596010455680,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Other,79,Female,,11/30/2011,4/4/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L28,12/17/2012,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 46-48MM OUTER DIAMETER SIZE D,71333323,10FM03833,71333323, ,03596010455604,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture of the Stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Trauma - Acute (e.g. Neck Of Femur),73,Female,,10/21/2012,12/17/2012,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L29,10/16/2014,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333324,09CM16622,71333324, ,03596010455611,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture of the Stem","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,56,Female,,7/2/2013,10/16/2014,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269430-1-L30,9/23/2015,10/23/2025,6/2/2025,REFLECTION XLPE Acetabular Liner,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333336,12JM05377,71333336, ,03596010455697,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, one (1) hip was later revised due to: Infection","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one thousand nine hundred and four (1,904) hips underwent primary THA procedures between 10-Feb-2004 and 22-Mar-2025, using a Reflection XLPE Liner. From these, thirty (30) hips were later revised due to the following reasons: six (6) hips due to dislocation/subluxation, six (6) hips due to infection, six (6) hips due to pain, six (6) hips due to periprosthetic fracture associated with the stem, two (2) hips due to aseptic loosening associated with the stem, two (2) hips due to lysis associated with the stem, two (2) hips due to malalignment associated with the socket, two (2) hips due to wear of acetabular component, one (1) hip due to incorrect sizing head, one (1) hip due to periprosthetic fracture associated with the socket and one (1) hip due to other/unknown reasons. It should be noted that more than one reason for revision may be associated with a revision surgery. ;Timeframe of Registry data: Implantations conducted between 10-Feb-2004 and 22-Mar-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Reflection Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand nine hundred and four (1,904) primary THA procedures with Reflection XLPE acetabular liners have been performed in the United Kingdom between 10-Feb-2004 and 22-Mar-2025. The mean cumulative revision rates for the Reflection XLPE acetabular liners were lower than the NJR Cementless primary THA class reported in the NJR 21st Annual Report 2024 (Table 3.H5) across all years of follow up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 0.42% (0.21%-0.84%) vs 0.92% (0.89%-0.94%) of the class.;o At 3rd postoperative year: 0.69% (0.40%-1.19%) vs 1.63% (1.60%-1.66%) of the class.;o At 5th postoperative year: 1.08% (0.70%-1.67%) vs 2.30% (2.26%-2.34%) of the class.;o At 10th postoperative year: 1.47% (1.0%-2.15%) vs 4.24% (4.18%-4.31%) of the class.;o At 15th postoperative year: 1.71% (1.19%-2.46%) vs 6.60% (6.48%-6.71%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",Indication for primary procedure: Osteoarthritis,65,Male,108,11/22/2013,9/23/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269537-1-L1, ,10/23/2025,5/15/2025,SPECTRON Femoral Stem,SPECTRON Femoral Stem, , , , , ,K970351, ,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from the United Kingdom, a total of eighty-one (81) hips underwent THA revision procedures upon which a SPECTRON Stem was placed in exchange of the primary femoral component. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from the United Kingdom, a total of eighty-one (81) hips underwent THA revision procedures upon which a SPECTRON Stem was placed in exchange of the primary femoral component. From these, four (4) hips required a re-revision due to the following reasons: one (1) of them due to adverse soft tissue reaction, two (2) due to femoral stem aseptic loosening, and two (2) due to acetabular socket aseptic loosening. It should be noted that multiple reasons for revision may be listed for a single revision surgery. ;Timeframe of Registry Data: Implantations conducted between 15-Apr-2003 and 22-Feb-2023.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Revision Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighty-one (81) procedures with SPECTRON EF Revision Stem have been performed in the United Kingdom between 15-Apr-2003 and 22-Feb-2023. The mean cumulative re-revision rates for SPECTRON EF Revision Stem were significantly lower than those for the Cemented Stems THR class in the NJR at 2 years of follow-up and onwards, as indicated by the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.3% (0.2%-3.7%) vs 3.6% (3.5% - 3.8%) of the class.;o At 2nd postoperative year: 1.3% (0.2% - 3.7%) vs 5.1% (4.9% - 5.3%) of the class.;o At 3rd postoperative year: 1.3% (0.2% - 3.8%) vs 6.1% (5.9% - 6.4%) of the class.;o At 4th postoperative year: 1.3% (0.2% - 4.0%) vs 7.0% (6.8% - 7.3%) of the class.;o At 5th postoperative year: 1.3% (0.2% - 4.0%) vs 8.0% (7.7% - 8.2%) of the class.;o At 6th postoperative year: 1.3% (0.2% - 4.2%) vs 8.9% (8.6% - 9.2%)of the class.;o At 7th postoperative year: 3.2% (0.8% - 7.6%) vs 9.7% (9.4% - 10.0%) of the class.;o At 8th postoperative year: 3.2% (0.8% - 7.9%) vs 10.5% (10.1% - 10.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269537-1-L2, ,10/23/2025,5/15/2025,SPECTRON Femoral Stem,SPECTRON Femoral Stem, , , , , ,K970351, ,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from the United Kingdom, a total of eighty-one (81) hips underwent THA revision procedures upon which a SPECTRON Stem was placed in exchange of the primary femoral component. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from the United Kingdom, a total of eighty-one (81) hips underwent THA revision procedures upon which a SPECTRON Stem was placed in exchange of the primary femoral component. From these, four (4) hips required a re-revision due to the following reasons: one (1) of them due to adverse soft tissue reaction, two (2) due to femoral stem aseptic loosening, and two (2) due to acetabular socket aseptic loosening. It should be noted that multiple reasons for revision may be listed for a single revision surgery. ;Timeframe of Registry Data: Implantations conducted between 15-Apr-2003 and 22-Feb-2023.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Revision Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighty-one (81) procedures with SPECTRON EF Revision Stem have been performed in the United Kingdom between 15-Apr-2003 and 22-Feb-2023. The mean cumulative re-revision rates for SPECTRON EF Revision Stem were significantly lower than those for the Cemented Stems THR class in the NJR at 2 years of follow-up and onwards, as indicated by the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.3% (0.2%-3.7%) vs 3.6% (3.5% - 3.8%) of the class.;o At 2nd postoperative year: 1.3% (0.2% - 3.7%) vs 5.1% (4.9% - 5.3%) of the class.;o At 3rd postoperative year: 1.3% (0.2% - 3.8%) vs 6.1% (5.9% - 6.4%) of the class.;o At 4th postoperative year: 1.3% (0.2% - 4.0%) vs 7.0% (6.8% - 7.3%) of the class.;o At 5th postoperative year: 1.3% (0.2% - 4.0%) vs 8.0% (7.7% - 8.2%) of the class.;o At 6th postoperative year: 1.3% (0.2% - 4.2%) vs 8.9% (8.6% - 9.2%)of the class.;o At 7th postoperative year: 3.2% (0.8% - 7.6%) vs 9.7% (9.4% - 10.0%) of the class.;o At 8th postoperative year: 3.2% (0.8% - 7.9%) vs 10.5% (10.1% - 10.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269537-1-L3, ,10/23/2025,5/15/2025,SPECTRON Femoral Stem,SPECTRON Femoral Stem, , , , , ,K970351, ,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from the United Kingdom, a total of eighty-one (81) hips underwent THA revision procedures upon which a SPECTRON Stem was placed in exchange of the primary femoral component. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from the United Kingdom, a total of eighty-one (81) hips underwent THA revision procedures upon which a SPECTRON Stem was placed in exchange of the primary femoral component. From these, four (4) hips required a re-revision due to the following reasons: one (1) of them due to adverse soft tissue reaction, two (2) due to femoral stem aseptic loosening, and two (2) due to acetabular socket aseptic loosening. It should be noted that multiple reasons for revision may be listed for a single revision surgery. ;Timeframe of Registry Data: Implantations conducted between 15-Apr-2003 and 22-Feb-2023.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Revision Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighty-one (81) procedures with SPECTRON EF Revision Stem have been performed in the United Kingdom between 15-Apr-2003 and 22-Feb-2023. The mean cumulative re-revision rates for SPECTRON EF Revision Stem were significantly lower than those for the Cemented Stems THR class in the NJR at 2 years of follow-up and onwards, as indicated by the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.3% (0.2%-3.7%) vs 3.6% (3.5% - 3.8%) of the class.;o At 2nd postoperative year: 1.3% (0.2% - 3.7%) vs 5.1% (4.9% - 5.3%) of the class.;o At 3rd postoperative year: 1.3% (0.2% - 3.8%) vs 6.1% (5.9% - 6.4%) of the class.;o At 4th postoperative year: 1.3% (0.2% - 4.0%) vs 7.0% (6.8% - 7.3%) of the class.;o At 5th postoperative year: 1.3% (0.2% - 4.0%) vs 8.0% (7.7% - 8.2%) of the class.;o At 6th postoperative year: 1.3% (0.2% - 4.2%) vs 8.9% (8.6% - 9.2%)of the class.;o At 7th postoperative year: 3.2% (0.8% - 7.6%) vs 9.7% (9.4% - 10.0%) of the class.;o At 8th postoperative year: 3.2% (0.8% - 7.9%) vs 10.5% (10.1% - 10.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269537-1-L4, ,10/23/2025,5/15/2025,SPECTRON Femoral Stem,SPECTRON Femoral Stem, , , , , ,K970351, ,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from the United Kingdom, a total of eighty-one (81) hips underwent THA revision procedures upon which a SPECTRON Stem was placed in exchange of the primary femoral component. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used in the NJR Implant Summary Report reviewed, no specific reason(s) for revision can be definitevly associated with the femoral stem referenced in this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from the United Kingdom, a total of eighty-one (81) hips underwent THA revision procedures upon which a SPECTRON Stem was placed in exchange of the primary femoral component. From these, four (4) hips required a re-revision due to the following reasons: one (1) of them due to adverse soft tissue reaction, two (2) due to femoral stem aseptic loosening, and two (2) due to acetabular socket aseptic loosening. It should be noted that multiple reasons for revision may be listed for a single revision surgery. ;Timeframe of Registry Data: Implantations conducted between 15-Apr-2003 and 22-Feb-2023.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Revision Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighty-one (81) procedures with SPECTRON EF Revision Stem have been performed in the United Kingdom between 15-Apr-2003 and 22-Feb-2023. The mean cumulative re-revision rates for SPECTRON EF Revision Stem were significantly lower than those for the Cemented Stems THR class in the NJR at 2 years of follow-up and onwards, as indicated by the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 1.3% (0.2%-3.7%) vs 3.6% (3.5% - 3.8%) of the class.;o At 2nd postoperative year: 1.3% (0.2% - 3.7%) vs 5.1% (4.9% - 5.3%) of the class.;o At 3rd postoperative year: 1.3% (0.2% - 3.8%) vs 6.1% (5.9% - 6.4%) of the class.;o At 4th postoperative year: 1.3% (0.2% - 4.0%) vs 7.0% (6.8% - 7.3%) of the class.;o At 5th postoperative year: 1.3% (0.2% - 4.0%) vs 8.0% (7.7% - 8.2%) of the class.;o At 6th postoperative year: 1.3% (0.2% - 4.2%) vs 8.9% (8.6% - 9.2%)of the class.;o At 7th postoperative year: 3.2% (0.8% - 7.6%) vs 9.7% (9.4% - 10.0%) of the class.;o At 8th postoperative year: 3.2% (0.8% - 7.9%) vs 10.5% (10.1% - 10.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;", , , , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L1,10/25/2012,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,12BT15358,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,66,Female, ,10/8/2012,10/25/2012,E161201;E1614,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L2,6/11/2013,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,12bt15382,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Female, ,7/13/2012,6/11/2013,E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L3,11/12/2013,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,12LT24992,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),79,Female, ,6/24/2013,11/12/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L4,11/25/2013,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,10LT01111,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),83,Female, ,12/6/2012,11/25/2013,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L5,12/12/2013,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 55OD XLPE,71358026,12JT22654,71358026, ,03596010481818,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,61,Male,113,5/8/2013,12/12/2013,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L6,9/18/2014,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 49OD XLPE,71358024,14CT40818,71358024, ,03596010481795,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female,88,8/7/2014,9/18/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L7,12/10/2014,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 52OD XLPE,71358025,12GT20791,71358025, ,03596010481801,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female,69,10/18/2013,12/10/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L8,12/11/2014,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 49OD XLPE,71358024,14DT41522,71358024, ,03596010481795,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Malalignment - Socket and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female,65,10/16/2014,12/11/2014,E2308;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L9,5/28/2015,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 55OD XLPE,71358026,12ET18453,71358026, ,03596010481818,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male,124,5/13/2014,5/28/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L10,7/7/2015,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 49OD XLPE,71358024,10gt44107,71358024, ,03596010481795,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Malalignment - Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female, ,2/10/2012,7/7/2015,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L11,9/23/2015,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 46OD XLPE,71358023,11MT13043,71358023, ,03596010481788,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Female,69,6/15/2012,7/7/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L12,8/2/2016,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 46OD XLPE,71358023,10CM02655,71358023, ,03596010481788,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - stem and Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,63,Female,114,3/12/2013,8/2/2016,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L13,9/15/2016,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 49OD XLPE,71358024,14GT43691,71358024, ,03596010481795,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female,92,12/11/2014,9/15/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L14,11/1/2016,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 58OD XLPE,71358037,16CT66260,71358037, ,03596010474278,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Male,89,9/8/2016, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L15,11/9/2016,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,13AT27434,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Previous Infection,53,Male,88,6/22/2016,11/9/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L16,7/10/2017,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 46OD XLPE,71358023,12CT16999,71358023, ,03596010481788,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,87,Female, ,11/19/2012,7/10/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L17,8/30/2017,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 52OD XLPE,71358035,13AT27432,71358035, ,03596010474254,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,80,Male, ,6/19/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L18,11/21/2017,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,12BT15382,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,72,Female, ,7/16/2012, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L19,2/9/2018,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,13ft32035,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male, ,12/23/2013, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L20,4/10/2018,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 55OD XLPE,71358036,17ft89070,71358036, ,03596010474261,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,71,Male,122,2/8/2018,4/10/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L21,5/9/2018,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,16gt72597,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Metastatic Cancer/Malignancy,81,Female, ,3/23/2018, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L22,7/17/2018,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 64OD XLPE,71358039,17bt82699,71358039, ,03596010474292,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,58,Male,108,6/25/2018,7/17/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L23,10/25/2018,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,14CT40819,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Other,77,Female,108,9/4/2014,10/25/2018,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L24,12/10/2018,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,16et70036,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Malalignment - Stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),57,Female, ,9/25/2017, ,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L25,12/10/2018,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,18ET03655,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Malalignment - Stem and Malalignment - Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Metastatic Cancer/Malignancy,79,Female, ,7/24/2018,12/10/2018,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L26,5/4/2020,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,17ET87583,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female,73,9/14/2017, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L27,5/12/2020,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,12FT20140,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Male, ,5/10/2013,5/12/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L28,7/23/2020,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,18CT01317,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),79,Male, ,5/9/2018, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L29,8/15/2020,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,17dt85929,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Trauma - Acute (e.g. Neck Of Femur),84,Female, ,8/29/2017,8/15/2020,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L30,8/26/2020,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,16LT78154,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - stem and Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female, ,3/22/2017, ,E161201;E2127,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L31,10/8/2020,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 55OD XLPE,71358036,18DT02360,71358036, ,03596010474261,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,73,Male, ,9/10/2020,10/8/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L32,12/10/2020,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 52OD XLPE,71358035,19AT15884,71358035, ,03596010474254,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Lysis - Stem and Lysis - Socket and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female,76,5/28/2019,12/10/2020,E1627;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L33,3/24/2021,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,17ft88864,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,79,Male, ,12/7/2017,3/24/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L34,6/4/2021,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,18JT10148,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket and Lysis - Socket and Peri-Prosthetic Fracture - Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female, ,3/13/2019,6/4/2021,E161201;E1627;E2127;E1614,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L35,6/8/2021,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,15FT55936,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - stem and Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,50,Female, ,11/30/2015, ,E161201;E2127,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L36,7/6/2021,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,14CT40816,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female, ,9/13/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L37,8/23/2021,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 52OD XLPE,71358035,20HT40562,71358035, ,03596010474254,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - stem and Malalignment - Socket and Peri-Prosthetic Fracture - Socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Female, ,7/30/2021,8/23/2021,E161201;E2308;E2127,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L38,8/25/2021,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,19jt27977,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Male,88,6/17/2020,8/25/2021,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L39,10/22/2021,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,21DT49437,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female,78,8/31/2021, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L40,12/9/2021,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 52OD XLPE,71358035,19et21693,71358035, ,03596010474254,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,92,Male,67,9/26/2019,12/9/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L41,3/18/2022,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 58,71358067,19JT28213,71358067, ,03596010533180,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,77,Male, ,10/26/2020,3/18/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L42,3/22/2022,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 52OD XLPE,71358035,12KT23780,71358035, ,03596010474254,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male, ,12/2/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L43,6/10/2022,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 46OD XLPE,71358023,21LT57059,71358023, ,03596010481788,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Female, ,2/15/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L44,8/10/2022,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 55,71358066,14BT39602,71358066, ,03596010533166,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male, ,9/22/2014, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L45,12/5/2022,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,18AT98419,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Previous Infection,63,Male, ,9/22/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L46,12/14/2022,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,21JT54508,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,89,Female, ,3/1/2022, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L47,2/14/2023,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 49OD XLPE,71358024,17DT86066,71358024, ,03596010481795,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Dislocation/Subluxation and Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female,56,8/24/2017,2/14/2023,E1614,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L48,3/1/2023,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 49OD XLPE,71358024,12et18451,71358024, ,03596010481795,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female,76,11/29/2019,3/1/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L49,4/16/2023,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,16JT75509,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Peri-Prosthetic Fracture - Stem and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,75,Female,69,3/17/2017, ,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L50,10/27/2023,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 55,71358066,16GT72893,71358066, ,03596010533166,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket and Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,81,Female,75,2/1/2019,10/27/2023,E161201,F1905,A0103;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L51,1/29/2024,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,19HT26370,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket and Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,68,Female, ,10/8/2022,1/29/2024,E161201,F1905,A0103;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L52,2/1/2024,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,12bt15382,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male, ,8/10/2012,2/1/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L53,5/21/2024,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 52OD XLPE,71358035,17et87584,71358035, ,03596010474254,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,74,Female, ,2/15/2019, ,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L54,8/23/2024,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,24AT79894,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Avascular Necrosis (AVN),84,Female, ,8/16/2024,8/23/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L55,10/15/2024,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 49OD XLPE,71358024,18BT99231,71358024, ,03596010481795,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,84,Female,76,12/3/2018,10/15/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L56,1/11/2025,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 58,71358067,23CT72877,71358067, ,03596010533180,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later revised due to Infection and Other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand three hundred fifty-four (3354) hips underwent primary THA procedures between 13-Sep-2006 and 18-Apr-2025, using a REFLECTION XLPE All-Poly cup. From these, fifty-six (56) hips were later revised due to the following reasons: ten (10) hips due to loosening ¿ socket, twelve (12) hips due to dislocation/subluxation, fourteen (14) hips due to infection, one (1) hip due to unexplained pain, four (4) hips due to malalignment socket, nineteen (19) hips due to peri-prosthetic fracture stem, four (4) hips due to loosening stem, two (2) hips due to malalignment stem, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, two (2) hips due to peri-prosthetic fracture socket, three (3) hips due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris and two (2) hips due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry data: Implantations conducted between 13-Sep-2006 and 18-Apr-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three thousand three hundred fifty-four (3354) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 18-Apr-2025. At all time points from 1 to 13 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 0.67% (0.44%-1.01%) vs 0.6% (0.6%-0.6%) of the class.;¿ At 3rd postoperative year: 1.09% (0.78%-1.52%) vs 1.1% (1.1%-1.1%) of the class.;¿ At 5th postoperative year: 1.62% (1.20%-2.18%) vs 1.5% (1.5%-1.5%) of the class.;¿ At 7th postoperative year: 2.20% (1.66%-2.93%) vs 1.9% (1.9%-2.0%) of the class.;¿ At 10th postoperative year: 2.42% (1.82%-3.23%) vs 2.8% (2.7%-2.8%) of the class.;¿ At 12th postoperative year: 2.76% (1.95%-3.90%) vs 3.5% (3.5%-3.6%) of the class.;¿ At 13th postoperative year: 2.76% (1.95%-3.90%) vs 3.9% (3.9%-4.0%) of the class.;;The most frequently reported reason for revision after primary THA with REFLECTION All-Poly XLPE Cup was loosening / lysis (n=17, 0.5%), followed by infection (n=14, 0.4%). Infection may occur due to the surgical environment or patients who are at high-risk and is not an inherent complication of the device. Loosening may occur to components co-implanted with the subject devices, such as femoral stems. All revised cases due to loosening were included in the analysis independently of the component affected. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male, ,12/28/2024, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272916-1-L1,3/24/2010,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 52OD XLPE,71358035,06hm14181,71358035, ,03596010474254,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later re-revised due to unexplained pain. ","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, six (6) hips were later re-revised due to the following reasons: two (2) hips due to unexplained pain, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, one (1) hip due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris, one (1) hip due to peri-prosthetic fracture ¿ stem, two (2) hips due to infection and one (1) hip due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each re-revision procedure.;Timeframe of Registry data: Implantations conducted between 23-Jan-2007 and 8-Jan-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifty (50) THA revision procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 23-Jan-2007 and 8-Jan-2025. At all time points from year 1 to 10, the Kaplan-Meier Re-revision Rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. However, due to the low number of patients at risk in the REFLECTION All-Poly XLPE Cup group, this data may not be statistically strongly reliable. The low number of patients at risk also contributes to the observed large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 4.23% (1.07%-15.90%) vs 3.4% (3.2%-3.6%) of the class.;¿ At 3rd postoperative year: 9.02% (3.47%-22.37%) vs 6.0% (5.8%-6.4%) of the class.;¿ At 5th postoperative year: 14.22% (6.62%-29.09%) vs 8.0% (7.6%-8.3%) of the class.;¿ At 7th postoperative year: 14.22% (6.62%-29.09%) vs 9.6% (9.2%-10.0%) of the class.;¿ At 10th postoperative year: 14.22% (6.62%-29.09%) vs 12.5% (12.0%-13.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Peri-Prosthetic Fracture Socket,83,Female, ,8/6/2007,3/24/2010,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272916-1-L2,6/20/2012,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 58,71358067,07fm12183,71358067, ,03596010533180,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, six (6) hips were later re-revised due to the following reasons: two (2) hips due to unexplained pain, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, one (1) hip due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris, one (1) hip due to peri-prosthetic fracture ¿ stem, two (2) hips due to infection and one (1) hip due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each re-revision procedure.;Timeframe of Registry data: Implantations conducted between 23-Jan-2007 and 8-Jan-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifty (50) THA revision procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 23-Jan-2007 and 8-Jan-2025. At all time points from year 1 to 10, the Kaplan-Meier Re-revision Rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. However, due to the low number of patients at risk in the REFLECTION All-Poly XLPE Cup group, this data may not be statistically strongly reliable. The low number of patients at risk also contributes to the observed large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 4.23% (1.07%-15.90%) vs 3.4% (3.2%-3.6%) of the class.;¿ At 3rd postoperative year: 9.02% (3.47%-22.37%) vs 6.0% (5.8%-6.4%) of the class.;¿ At 5th postoperative year: 14.22% (6.62%-29.09%) vs 8.0% (7.6%-8.3%) of the class.;¿ At 7th postoperative year: 14.22% (6.62%-29.09%) vs 9.6% (9.2%-10.0%) of the class.;¿ At 10th postoperative year: 14.22% (6.62%-29.09%) vs 12.5% (12.0%-13.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Unexplained Pain,61,Male,123,10/1/2010,6/20/2012,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272916-1-L3,2/6/2013,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,06HM20862,71358034, ,03596010474247,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later re-revised due to Peri-Prosthetic fracture - stem. ","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, six (6) hips were later re-revised due to the following reasons: two (2) hips due to unexplained pain, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, one (1) hip due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris, one (1) hip due to peri-prosthetic fracture ¿ stem, two (2) hips due to infection and one (1) hip due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each re-revision procedure.;Timeframe of Registry data: Implantations conducted between 23-Jan-2007 and 8-Jan-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifty (50) THA revision procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 23-Jan-2007 and 8-Jan-2025. At all time points from year 1 to 10, the Kaplan-Meier Re-revision Rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. However, due to the low number of patients at risk in the REFLECTION All-Poly XLPE Cup group, this data may not be statistically strongly reliable. The low number of patients at risk also contributes to the observed large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 4.23% (1.07%-15.90%) vs 3.4% (3.2%-3.6%) of the class.;¿ At 3rd postoperative year: 9.02% (3.47%-22.37%) vs 6.0% (5.8%-6.4%) of the class.;¿ At 5th postoperative year: 14.22% (6.62%-29.09%) vs 8.0% (7.6%-8.3%) of the class.;¿ At 7th postoperative year: 14.22% (6.62%-29.09%) vs 9.6% (9.2%-10.0%) of the class.;¿ At 10th postoperative year: 14.22% (6.62%-29.09%) vs 12.5% (12.0%-13.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,76,Female,57,12/9/2009, ,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272916-1-L4,2/28/2013,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 58,71358067,08hm19097,71358067, ,03596010533180,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later re-revised due to Lysis Stem, Lysis Socket, Unexplained Pain, Wear of Acetabular Component and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, six (6) hips were later re-revised due to the following reasons: two (2) hips due to unexplained pain, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, one (1) hip due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris, one (1) hip due to peri-prosthetic fracture ¿ stem, two (2) hips due to infection and one (1) hip due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each re-revision procedure.;Timeframe of Registry data: Implantations conducted between 23-Jan-2007 and 8-Jan-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifty (50) THA revision procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 23-Jan-2007 and 8-Jan-2025. At all time points from year 1 to 10, the Kaplan-Meier Re-revision Rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. However, due to the low number of patients at risk in the REFLECTION All-Poly XLPE Cup group, this data may not be statistically strongly reliable. The low number of patients at risk also contributes to the observed large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 4.23% (1.07%-15.90%) vs 3.4% (3.2%-3.6%) of the class.;¿ At 3rd postoperative year: 9.02% (3.47%-22.37%) vs 6.0% (5.8%-6.4%) of the class.;¿ At 5th postoperative year: 14.22% (6.62%-29.09%) vs 8.0% (7.6%-8.3%) of the class.;¿ At 7th postoperative year: 14.22% (6.62%-29.09%) vs 9.6% (9.2%-10.0%) of the class.;¿ At 10th postoperative year: 14.22% (6.62%-29.09%) vs 12.5% (12.0%-13.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Loosening - socket,72,Female, ,10/22/2009,2/28/2013,E1627;E2330;E040203,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272916-1-L5,5/14/2019,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 46OD XLPE,71358023,18BT00431,71358023, ,03596010481788,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later re-revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, six (6) hips were later re-revised due to the following reasons: two (2) hips due to unexplained pain, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, one (1) hip due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris, one (1) hip due to peri-prosthetic fracture ¿ stem, two (2) hips due to infection and one (1) hip due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each re-revision procedure.;Timeframe of Registry data: Implantations conducted between 23-Jan-2007 and 8-Jan-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifty (50) THA revision procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 23-Jan-2007 and 8-Jan-2025. At all time points from year 1 to 10, the Kaplan-Meier Re-revision Rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. However, due to the low number of patients at risk in the REFLECTION All-Poly XLPE Cup group, this data may not be statistically strongly reliable. The low number of patients at risk also contributes to the observed large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 4.23% (1.07%-15.90%) vs 3.4% (3.2%-3.6%) of the class.;¿ At 3rd postoperative year: 9.02% (3.47%-22.37%) vs 6.0% (5.8%-6.4%) of the class.;¿ At 5th postoperative year: 14.22% (6.62%-29.09%) vs 8.0% (7.6%-8.3%) of the class.;¿ At 7th postoperative year: 14.22% (6.62%-29.09%) vs 9.6% (9.2%-10.0%) of the class.;¿ At 10th postoperative year: 14.22% (6.62%-29.09%) vs 12.5% (12.0%-13.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,17,Female,109,1/21/2019, ,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272916-1-L6,5/22/2023,10/23/2025,6/3/2025,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,19AT15131,71358065, ,03596010533173,K002747, ,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of fifty (50) hips underwent revision THA procedures between 23-Jan-2007 and 8-Jan-2025, using a REFLECTION XLPE All-Poly cup. From these, six (6) hips were later re-revised due to the following reasons: two (2) hips due to unexplained pain, one (1) hip due to lysis ¿ stem, one (1) hip due to lysis ¿ socket, one (1) hip due to wear of acetabular component, one (1) hip due to adverse soft tissue reaction to particulate debris, one (1) hip due to peri-prosthetic fracture ¿ stem, two (2) hips due to infection and one (1) hip due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for each re-revision procedure.;Timeframe of Registry data: Implantations conducted between 23-Jan-2007 and 8-Jan-2025 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifty (50) THA revision procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 23-Jan-2007 and 8-Jan-2025. At all time points from year 1 to 10, the Kaplan-Meier Re-revision Rate of the REFLECTION All-Poly XLPE Cup is in line with the class, as defined by overlapping confidence intervals. However, due to the low number of patients at risk in the REFLECTION All-Poly XLPE Cup group, this data may not be statistically strongly reliable. The low number of patients at risk also contributes to the observed large confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 4.23% (1.07%-15.90%) vs 3.4% (3.2%-3.6%) of the class.;¿ At 3rd postoperative year: 9.02% (3.47%-22.37%) vs 6.0% (5.8%-6.4%) of the class.;¿ At 5th postoperative year: 14.22% (6.62%-29.09%) vs 8.0% (7.6%-8.3%) of the class.;¿ At 7th postoperative year: 14.22% (6.62%-29.09%) vs 9.6% (9.2%-10.0%) of the class.;¿ At 10th postoperative year: 14.22% (6.62%-29.09%) vs 12.5% (12.0%-13.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision: Lysis Stem, Lysis Socket, Infection",81,Male, ,9/23/2022, ,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L1,7/24/2007,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 10,71357010,6AM12599A,71357010,,03596010559531,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,50,Female,,7/17/2007,7/24/2007,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L2,1/28/2009,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,7GM18740A,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,83,Female,,1/23/2009,1/28/2009,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L3,1/30/2009,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,1,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,58,Female,,8/13/2007,1/30/2009,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L4,3/27/2009,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,1,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Female,,5/31/2007,3/27/2009,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L5,5/13/2009,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,1,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Male,,5/17/2007,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L6,6/10/2009,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,08fm10220a,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Male,75,6/9/2009,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L7,8/14/2009,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 10,71357010,1,71357010,,03596010559531,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Congenital Dislocation/Dysplasia of the Hip.,64,Female,,10/25/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L8,8/19/2009,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 2,71357002,05mm03937a,71357002,,03596010559456,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem,Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Female,,3/25/2008,,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L9,10/15/2009,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 2,71357002,06CM03793A,71357002,,03596010559456,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain,other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Female,,1/11/2008,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L10,2/2/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,1,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Female,,4/16/2007,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L11,3/11/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 2,71357002,7LM07292A,71357002,,03596010559456,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,10/16/2008,8/4/2011,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L12,3/16/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 12,71357012,1,71357012,,03596010559555,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,77,Male,,9/29/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L13,4/9/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,07EM09524A,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,75,Female,,9/19/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L14,4/27/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,7JM16105A,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Wear of Acetabular Component.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,,6/3/2008,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L15,5/6/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,124,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Female,,3/17/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L16,5/11/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,7FM16008A,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Female,,8/13/2008,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L17,5/12/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,111,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Female,,12/18/2008,3/2/2013,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L18,5/13/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,111,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,44,Female,,11/6/2008,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L19,8/31/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, other-unknown reasons.",64,Female,,3/2/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L20,9/10/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,111,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Male,,9/5/2008,9/10/2013,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L21,10/1/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,06BM10497A,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Female,65,6/2/2008,9/25/2013,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L22,10/13/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,1,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,4/12/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L23,11/3/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,7HM23081A,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,84,Female,,5/23/2008,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L24,11/17/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,8CM17558A,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,,10/30/2008,10/22/2013,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L25,11/25/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,7GM18725A,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Female,,4/30/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L26,12/1/2010,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,8DM17375A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening of the socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,56,Female,,2/21/2009,,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L27,4/1/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,06AM04607A,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,56,Female,,7/20/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L28,4/5/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,111,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Male,,9/2/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L29,4/7/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,1,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Female,,1/30/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L30,6/8/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,1,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,,12/21/2006,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L31,6/8/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,1,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,,5/17/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L32,6/17/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,7FM03998A,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Female,,5/12/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L33,7/19/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,1,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,,8/22/2006,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L34,7/29/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,05MM10369A,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Male,,7/11/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L35,8/2/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,10f,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,81,Male,,7/21/2011,4/2/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L36,8/4/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,7JM14044A,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Male,79,9/4/2008,4/28/2015,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L37,8/4/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,06MM09158A,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Male,,7/22/2010,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L38,8/31/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,1,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,55,Female,,1/22/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L39,9/19/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,10cm15763a,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Head/Socket Mismatch - Head,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Male,,11/8/2010,,E2401;E040203,F1905,A24;A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L40,9/20/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,1,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Male,,11/10/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L41,9/23/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,8CM02783A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,,6/18/2008,11/23/2015,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L42,11/2/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,111,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Male,,6/25/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L43,11/24/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,1,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Female,,1/2/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L44,12/9/2011,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 1,71357001,111,71357001,,03596010559449,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Lysis Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Avascular Necrosis (AVN), Osteoarthritis.",45,Female,,9/9/2008,,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L45,2/29/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,111,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Female,,11/21/2008,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L46,3/8/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,1,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Male,,3/22/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L47,3/16/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,1,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,,10/26/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L48,3/21/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,7EM17088A,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain, Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Male,,12/15/2008,,E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L49,3/26/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,11cm09990a,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Lysis Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,89,Male,72,12/12/2011,9/5/2016,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L50,3/30/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 11,71357111,10LM14195A,71357111,,03596010559661,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Male,,1/6/2012,10/3/2016,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L51,4/17/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,1,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Female,,2/23/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L52,5/1/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,125,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Male,,8/11/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L53,5/9/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,1,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Male,,8/16/2007,12/13/2016,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L54,5/24/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,11am16933,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Wear of Acetabular Component.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,,8/26/2011,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L55,5/31/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,1,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Female,,3/11/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L56,6/1/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,1,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Male,,2/6/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L57,6/1/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,1,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,,3/2/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L58,6/28/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,111,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Female,,4/1/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L59,7/5/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,6AM19249A,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Female,,5/2/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L60,7/6/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,11LM06558,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection,Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,94,5/11/2012,,E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L61,7/19/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,111,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,,8/22/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L62,7/27/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 10,71357010,06AM12599A,71357010,,03596010559531,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Male,,1/31/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L63,7/27/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,1,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Female,,1/2/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L64,9/12/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,12AM03119,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,63,Male,94,4/4/2012,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L65,9/13/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,1,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Avascular Necrosis (AVN).,50,Male,,7/11/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L66,9/19/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,1,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,60,Male,,11/29/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L67,9/28/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 9,71357109,1,71357109,,03596010559647,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,8/3/2007,,E1906;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L68,10/1/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,12am03118,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket,Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,44,Female,72,9/10/2012,,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L69,10/10/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,111,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Female,,12/19/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L70,10/11/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,7LM02598A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Female,63,10/16/2008,9/11/2018,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L71,10/18/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,111,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Female,,1/6/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L72,10/29/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,08AM02581A,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Female,,12/21/2011,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L73,10/30/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,08FM12297A,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Trauma - Acute (e.g. Neck Of Femur).,68,Female,,4/1/2010,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L74,11/6/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,1,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,,6/29/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L75,11/7/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 2,71357102,5MM02049A,71357102,,03596010559579,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Female,,3/12/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L76,11/27/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,111,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Congenital Dislocation/Dysplasia of the Hip.,50,Female,,12/2/2008,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L77,11/27/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,10dm05188a,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Wear of Acetabular Component.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,87,Male,,10/23/2012,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L78,12/4/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,7EM02605A,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,3/31/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L79,12/20/2012,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,1,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Female,,2/7/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L80,1/22/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 2,71357102,111,71357102,,03596010559579,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Female,,9/9/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L81,1/29/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,1,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,,12/12/2006,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L82,1/29/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,06AM04654A,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,,4/13/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L83,2/5/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 9,71357109,1,71357109,,03596010559647,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,5/26/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L84,2/5/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,1,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Female,,7/27/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L85,3/2/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 1,71357001,12FM15772,71357001,,03596010559449,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,60,Male,145,2/27/2013,12/30/2021,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L86,3/13/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,1,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Female,,1/23/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L87,4/16/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,05mm03498a,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,52,Male,,3/14/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L88,5/10/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,123,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Female,,12/19/2008,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L89,5/30/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,1,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Fractured Neck of Femur.,82,Male,,2/13/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L90,7/1/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,07m,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket,Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Female,,7/7/2011,,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L91,7/23/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,1,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,60,Male,,5/4/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L92,8/1/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,12FM13169,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,48,Female,90,1/31/2013,7/19/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L93,8/7/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,11HM13383,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem,Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Male,135,2/20/2012,7/21/2023,E2127;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L94,8/29/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,08LM02411A,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection,Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: other-unknown reasons Inflammatory Arthropathy.,70,Female,,2/9/2010,,E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L95,9/10/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,2LM14812,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem,Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,39,Male,85,8/28/2013,12/6/2023,E161201;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L96,9/12/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,08MM18366A,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,112,9/1/2011,,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L97,9/24/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,08lm00200a,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Lysis Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,12/8/2009,,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L98,9/25/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,13em04277,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Implant Fracture - stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,79,Female,,8/23/2013,10/2/2024,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L99,10/8/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,111,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Male,,8/12/2008,11/16/2024,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L100,10/8/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,8EM22350A,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,49,Male,,8/12/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L101,10/15/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,1,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,79,Female,,3/27/2007,10/15/2013,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L102,10/15/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 2,71357102,6BM02989A,71357102,,03596010559579,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,54,Female,,3/12/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L103,10/22/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,12BM00508,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,66,10/9/2013,10/22/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L104,10/24/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,1,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,,7/4/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L105,10/29/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,123,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection,other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Male,,8/12/2008,10/29/2013,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L106,11/12/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,1,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,84,Female,,7/23/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L107,11/14/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,3BM04899A,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket,Peri-Prosthetic Fracture Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Female,61,9/3/2013,11/14/2013,E2308;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L108,11/14/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,13fm14660,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Male,80,10/29/2013,11/14/2013,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L109,11/21/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,06bm02996a,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,80,Female,,8/15/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L110,11/26/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,1,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,82,Female,,11/21/2006,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L111,12/3/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,1,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Female,,9/11/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L112,12/6/2013,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,12mm11877,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dissociation of liner.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,,9/3/2013,12/6/2013,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L113,1/20/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,1,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,6/1/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L114,1/21/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,1,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,82,Male,,7/23/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L115,2/11/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,1,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Female,,6/26/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L116,2/20/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,07CM04980,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,75,Female,,9/20/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L117,2/26/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,12BM01170,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Avascular Necrosis (AVN), Trauma - Chronic.",50,Male,87,10/29/2013,2/26/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L118,4/9/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,3FM18709,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Female,,2/19/2014,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L119,4/11/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,7FM02638A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,57,Female,101,4/11/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L120,4/15/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,111,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: other-unknown reasons.,38,Male,,3/17/2009,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L121,6/17/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,1,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Female,,4/23/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L122,6/30/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,05LM04861A,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,50,Female,76,2/27/2013,6/30/2014,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L123,7/8/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,1,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Female,,7/2/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L124,8/12/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,6LM02187A,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,,5/6/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L125,9/8/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,1,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Male,,4/4/2007,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L126,9/18/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,7JM01712A,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Fractured Neck of Femur.,83,Female,,4/17/2008,,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L127,9/23/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,1,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Congenital Dislocation/Dysplasia of the Hip.,75,Male,,4/24/2007,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L128,10/9/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,08mm13958a,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening - socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, other-unknown reasons.",70,Male,75,10/9/2009,,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L129,10/9/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,13gm03888,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Wear of Acetabular Component.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,,2/10/2014,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L130,10/16/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,444,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,7/26/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L131,10/20/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,07AM16044A,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Male,,11/8/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L132,10/20/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,07em23099a,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,4/6/2010,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L133,11/3/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,7FM02642A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Fractured Neck of Femur, Osteoarthritis.",67,Female,,4/17/2008,11/3/2014,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L134,11/3/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,13FM08123,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,55,Female,,11/25/2013,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L135,11/4/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,1,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,,12/19/2006,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L136,11/5/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 11,71357011,1,71357011,,03596010559548,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,5/30/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L137,11/6/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,07DM04875A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,,7/19/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L138,11/7/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,07asm16043a,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dissociation of liner.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Female,,9/13/2007,,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L139,11/7/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 2,71357102,13em09262,71357102,,03596010559579,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Female,,2/11/2014,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L140,11/25/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 11,71357011,06AM12606A,71357011,,03596010559548,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Female,,12/11/2006,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L141,12/2/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,12lm11416,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Female,,3/4/2014,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L142,12/16/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,1,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,78,Male,,1/27/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L143,12/23/2014,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,12mm11877,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Male,,11/27/2014,12/23/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L144,1/20/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,09HM,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Female,,7/2/2013,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L145,2/5/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,08km09766a,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Female,,5/6/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L146,2/10/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 2,71357102,7MM09494A,71357102,,03596010559579,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,80,Male,,6/23/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L147,3/5/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,6MM09158A,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,75,Female,,5/27/2008,3/5/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L148,3/10/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,1,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,,5/8/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L149,3/18/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,14HM01597,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, other-unknown reasons.",67,Male,109,2/11/2015,3/18/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L150,3/21/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,10lm09806a,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Female,70,9/19/2011,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L151,4/2/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 10,71357010,8BM04975A,71357010,,03596010559531,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Lysis Socket,Infection,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,10/8/2009,4/2/2015,E040203;E1627;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L152,4/21/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,1,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,63,Male,,1/30/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L153,4/28/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,08LM02411A,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,,3/16/2010,4/28/2015,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L154,5/12/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,06AM04661A,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Male,83,7/6/2010,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L155,6/5/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,13BM07049A,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Male,85,10/16/2014,6/5/2015,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L156,6/8/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 11,71357111,08lm08244a,71357111,,03596010559661,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Congenital Dislocation/Dysplasia of the Hip, Osteoarthritis.",66,Male,,11/22/2010,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L157,6/18/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,111,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,85,Male,103,8/4/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L158,6/25/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,7KM00645A,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,57,Male,76,3/6/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L159,7/9/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,14FM04622,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: other-unknown reasons.,39,Female,,6/26/2015,7/9/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L160,7/14/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,12km12580,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,6/8/2015,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L161,7/28/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,13lm13631,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,54,Female,47,2/27/2015,7/28/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L162,9/22/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,1,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,78,Male,,1/30/2007,9/22/2015,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L163,9/23/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,111,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,12/12/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L164,10/7/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,111,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,56,Female,,9/1/2008,,E2401;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L165,10/13/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,7AM02995A,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Female,,10/8/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L166,10/23/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,08mm1,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Wear of Acetabular Component.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,,5/22/2010,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L167,11/17/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,08KM19740A,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Female,98,2/24/2010,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L168,11/19/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 2,71357002,09CM11866A,71357002,,03596010559456,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: other-unknown reasons.,40,Female,59,5/15/2014,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L169,11/23/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,14fm16700,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,49,Female,,11/5/2015,11/23/2015,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L170,11/24/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,09HM03954A,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,63,Female,,6/1/2010,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L171,12/7/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 11,71357011,12gm03233,71357011,,03596010559548,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,52,Male,,3/24/2014,12/7/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L172,12/16/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,15em15576,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,77,9/7/2015,12/16/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L173,12/22/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,15gm16826,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,52,Male,,12/8/2015,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L174,12/22/2015,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,15em16367,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,52,Male,,12/8/2015,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L175,1/27/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 11,71357011,06cm04521a,71357011,,03596010559548,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Male,,9/22/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L176,2/22/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,13em16257,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,78,Male,,11/19/2013,2/22/2016,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L177,3/15/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,1,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Female,,7/3/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L178,4/11/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,13EM16034,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Congenital Dislocation/Dysplasia of the Hip, Osteoarthritis.",57,Female,70,8/27/2013,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L179,4/12/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,8CM17556A,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,79,Male,,11/5/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L180,4/12/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,15JM15567,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Male,117,12/29/2015,4/12/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L181,5/3/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,8DM09600B,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Male,,9/30/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L182,5/21/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,15MM09660,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Perthes.,29,Male,,5/19/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L183,7/12/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,1,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Female,,9/29/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L184,7/15/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 9,71357109,1,71357109,,03596010559647,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,84,Male,,5/8/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L185,7/28/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,16am10883,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,,6/20/2016,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L186,8/1/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,07CM06994,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, other-unknown reasons.",70,Male,68,10/22/2007,8/1/2016,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L187,8/4/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,07bm08697b,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Female,74,5/6/2015,8/4/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L188,8/10/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,3BM04294A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Trauma - Chronic.,51,Female,60,10/4/2013,8/10/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L189,9/5/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,13AM08639,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,54,Female,77,12/18/2013,9/5/2016,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L190,10/3/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,13GM03864,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem,Malalignment Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,56,Male,,12/8/2014,10/3/2016,E161201;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L191,10/17/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 10,71357010,06HM07926A,71357010,,03596010559531,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Male,,3/11/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L192,11/1/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 12,71357112,14fm14329,71357112,,03596010559678,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,9/19/2016,11/1/2016,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L193,11/5/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 2,71357102,14BM22075,71357102,,03596010559579,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem,Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Male,77,7/29/2016,11/5/2016,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L194,11/7/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,09dm21659a,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, other-unknown reasons.",65,Female,,12/18/2009,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L195,11/29/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,07bm11432,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, other-unknown reasons.",78,Male,87,9/26/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L196,12/13/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,7MM00948A,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Female,,3/4/2009,12/13/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L197,12/14/2016,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,1,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Male,,10/4/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L198,2/3/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,1,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation,Head/Socket Mismatch - Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,86,Female,,9/28/2007,,E1614,F1905,A24;A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L199,2/6/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,1,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,84,Female,,5/14/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L200,2/9/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,1,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Lysis Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,78,Male,,10/7/2006,,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L201,2/10/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,16DM05881,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,91,1/25/2017,2/10/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L202,3/23/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 9,71357109,06am06566a,71357109,,03596010559647,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: other-unknown reasons.,71,Male,73,8/8/2007,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L203,4/25/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,14fm04613,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,,9/9/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L204,5/16/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,1,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,81,Female,,5/26/2007,8/2/2017,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L205,7/22/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,17cm17187,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,39,Female,,7/12/2017,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L206,7/27/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,12HM00635,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,,1/7/2013,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L207,8/1/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,16cm13123,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem,Loosening - socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, Previous Hip Surgery - Non Trauma Related.",70,Male,,9/14/2016,10/13/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L208,8/2/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,16GM16509,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Male,,7/11/2017,11/29/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L209,9/20/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,09GM10830A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Female,92,6/28/2011,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L210,9/20/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,12KM10301A,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,86,3/21/2017,3/13/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L211,10/5/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,7jm05520a,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Female,,11/30/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L212,10/5/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,16cm16691,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,55,Female,,9/6/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L213,10/12/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,12jm09530,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,83,Female,,8/9/2013,4/24/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L214,10/13/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,15LM07112,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,57,Male,104,10/10/2017,6/14/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L215,11/29/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,15JM03788,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem,other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,55,Female,82,7/21/2016,6/20/2018,E161201;E2401,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L216,12/26/2017,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,13em16034,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Female,80,12/4/2017,9/11/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L217,1/11/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,111,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Male,,10/24/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L218,2/7/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,111,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,63,Female,,11/19/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L219,3/12/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,10km17564a,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Stem,Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,55,Male,,5/23/2011,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L220,3/13/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,15gm18619,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,66,6/16/2015,1/23/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L221,3/23/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,17em05914,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,50,Female,,11/29/2017,2/15/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L222,4/9/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,12gm14239,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Implant Fracture - stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,77,Male,,2/26/2016,3/21/2019,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L223,4/24/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,14AM23193,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,57,Female,92,7/12/2016,5/24/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L224,5/28/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,08fm06891a,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Female,,11/10/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L225,6/14/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,16cm09679,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,75,Male,,11/12/2016,9/6/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L226,6/20/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,12JM15955A,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,78,Female,60,6/27/2013,11/1/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L227,7/31/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 2,71357002,111,71357002,,03596010559456,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,54,Female,,6/27/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L228,8/21/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,15em15581,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,81,Male,,11/3/2015,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L229,8/21/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,17GM15046,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Female,,11/22/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L230,9/11/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,15em16351,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Male,101,6/1/2016,12/18/2020,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L231,9/11/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 3,71357103,15em06850,71357103,,03596010559586,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,49,Male,,1/18/2017,12/20/2021,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L232,9/18/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,06am0654a,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening - socket,Dissociation of liner.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Female,,5/21/2009,,E161201;E2401,F1905,A0102;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L233,12/1/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 10,71357010,08bm20432a,71357010,,03596010559531,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket,Wear of Acetabular Component.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: other-unknown reasons.,77,Female,,2/5/2009,,E2308;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L234,12/11/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,16cm13077,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Lysis Stem,Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Female,77,4/7/2017,5/10/2022,E2308;E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L235,12/17/2018,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,10hm06086a,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Female,,6/22/2015,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L236,1/19/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,17HM17074B,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,52,Male,,6/4/2018,10/10/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L237,1/23/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,16CM02768,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem,Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,45,Male,107,2/21/2018,11/23/2022,E161201;E1614,F1905,A24;A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L238,1/31/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,13FM04727,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Congenital Dislocation/Dysplasia of the Hip, Osteoarthritis.",45,Female,74,7/23/2014,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L239,2/6/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,12BM01404,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Female,71,7/24/2012,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L240,2/15/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,10mm08333a,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Male,105,8/26/2011,7/21/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L241,2/22/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 9,71357109,07H,71357109,,03596010559647,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,84,Female,,12/7/2009,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L242,3/21/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,12LM02749,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,47,Female,82,9/10/2014,12/6/2023,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L243,3/25/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,05mm03944a,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Avascular Necrosis (AVN).,68,Male,87,8/6/2012,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L244,5/13/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 2,71357102,14fm04620,71357102,,03596010559579,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Female,,4/28/2017,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L245,5/15/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,111,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,54,Female,,11/21/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L246,5/24/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,13gm03394,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Stem,Malalignment Socket,Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,44,Male,,2/20/2019,11/16/2024,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L247,6/24/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,16JM16187A,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,10/2/2018,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L248,8/6/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,124,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Trauma - Chronic.,49,Male,,3/17/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L249,8/20/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,07fm02638,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: other-unknown reasons.,82,Female,,2/12/2008,8/20/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L250,9/6/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,1,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,86,Female,,7/20/2007,9/6/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L251,10/9/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,17DM12171,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,75,Female,,9/22/2017,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L252,11/1/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,13fm03072,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Avascular Necrosis (AVN), Osteoarthritis.",57,Male,,2/26/2019,11/1/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L253,11/7/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,08mm17202a,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, other-unknown reasons.",69,Male,,3/26/2010,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L254,12/30/2019,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 2,71357002,09bm19691c,71357002,,03596010559456,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: other-unknown reasons.,21,Female,,7/23/2014,,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L255,2/3/2020,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 11,71357111,12JM08862,71357111,,03596010559661,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,44,Male,89,2/3/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L256,2/28/2020,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,17MM08262,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,63,Female,,9/17/2018,2/28/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L257,10/6/2020,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,20gm13194,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,58,Female,,10/5/2020,10/6/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L258,11/10/2020,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,09HM18305A,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Osteoarthritis, other-unknown reasons.",77,Male,84,4/10/2010,11/10/2020,E1906;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L259,11/10/2020,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,17MM17203,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,,8/28/2018,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L260,12/18/2020,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,08am12178a,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,77,Female,,12/12/2008,12/18/2020,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L261,4/28/2021,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,15em08061,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: other-unknown reasons.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,40,Female,70,8/7/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L262,6/30/2021,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,6AM08943A,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,77,Male,,4/1/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L263,9/28/2021,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,16em15991,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,85,Male,,3/13/2018,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L264,10/12/2021,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,09HM03952A,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,77,Female,,5/25/2010,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L265,12/20/2021,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 1,71357101,08BM09387A,71357101,,03596010559562,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,58,Female,,2/15/2012,12/20/2021,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L266,12/30/2021,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,17bm13107,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Avascular Necrosis (AVN), Osteoarthritis.",73,Male,,10/9/2018,12/30/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L267,1/25/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 7,71357107,17AM08986,71357107,,03596010559623,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Avascular Necrosis (AVN), Osteoarthritis.",43,Male,,11/2/2018,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L268,2/3/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,6AM02725A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,83,Male,,2/12/2009,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L269,2/23/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,7FM03998A,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Female,51,5/16/2008,2/23/2022,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L270,3/9/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,09AM08997A,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Lysis Socket,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Female,,9/16/2009,,E1627;E040203,F1905,A24;A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L271,4/26/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,13jm14643,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening - socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Male,111,5/10/2014,,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L272,5/10/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,19GM21936,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Female,,2/25/2022,5/10/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L273,5/24/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,1,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening - socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,84,Female,,4/12/2007,,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L274,6/24/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 11,71357111,06A,71357111,,03596010559661,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,85,Male,,3/2/2010,6/24/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L275,10/10/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,22cm07703,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,80,9/6/2022,10/10/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L276,11/23/2022,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,10LM11574A,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,81,Female,,5/23/2012,11/23/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L277,1/9/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,20AM00813,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure: Avascular Necrosis (AVN), Osteoarthritis, Previous Hip Surgery - Non Trauma Related.",46,Female,85,5/10/2021,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L278,1/11/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,156,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Malalignment Socket,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,47,Male,,3/24/2009,,E2308;E040203,F1905,A24;A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L279,1/17/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 9,71357009,1,71357009,,03596010559524,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,77,Female,,7/30/2007,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L280,5/17/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,12am11275,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,43,Female,,5/11/2012,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L281,5/20/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,20AM00826,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,36,Male,,5/24/2021,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L282,7/19/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,18EM14080,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Unexplained Pain,Leg Length Discrepancy.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Female,,7/30/2021,7/19/2023,E2330;E1634,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L283,7/19/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 8,71357108,16em03451,71357108,,03596010559630,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Male,,1/18/2023,7/19/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L284,7/21/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 4,71357104,11HM13386,71357104,,03596010559593,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,79,Female,,1/17/2013,7/21/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L285,8/28/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,15LM15605,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,80,Female,,7/26/2016,8/28/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L286,12/6/2023,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 9,71357109,06AM06565A,71357109,,03596010559647,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,81,Male,,5/14/2007,12/6/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L287,1/5/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 7,71357007,21JM03982,71357007,,03596010559500,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,78,Female,,12/9/2023,1/5/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L288,2/16/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 5,71357105,17FM16606,71357105,,03596010559609,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,53,Female,92,12/5/2017,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L289,2/28/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 10,71357110,14b,71357110,,03596010559654,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,49,Male,,10/10/2022,,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L290,5/24/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,16bm12151,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation,Wear of Acetabular Component,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,56,Female,47,1/3/2018,,E1614;E040203,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L291,6/25/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,23JM14157,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,46,Female,,5/22/2024,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L292,6/28/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,111,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,50,Female,,11/12/2008,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L293,8/14/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,13EM05491,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Female,65,7/24/2013,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L294,8/28/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 8,71357008,13HM12885,71357008,,03596010559517,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Leg Length Discrepancy,Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,81,Female,63,11/19/2013,8/28/2024,E1634;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L295,9/16/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,16dm10807,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,77,Male,95,7/5/2016,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L296,10/2/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 4,71357004,12BM04694,71357004,,03596010559470,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,86,Female,65,9/7/2012,10/2/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L297,11/12/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 3,71357003,16lm17122a,71357003,,03596010559463,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Dislocation/Subluxation,Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,36,Female,77,5/26/2017,,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L298,11/16/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,24DM07092,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,80,Male,,11/13/2024,11/16/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L299,11/18/2024,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 6,71357006,09mm,71357006,,03596010559494,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Implant Fracture of a ceramic component - Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,86,Female,,11/19/2010,11/18/2024,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L300,4/8/2025,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY STANDARD OFFSET POROUS PLUS HA SIZE 5,71357005,111,71357005,,03596010559487,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,,10/24/2008,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00287067-1-L301,4/28/2025,10/23/2025,9/17/2025,ANTHOLOGY Hip System,ANTHOLOGY HIGH OFFSET POROUS PLUS HA SIZE 6,71357106,21MM06035,71357106,,03596010559616,K052792,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, one (1) hip was later revised due to: Loosening stem,Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025) ;;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of seven thousand and eighty-five (7085) hips underwent primary THA between 21-Aug-2006 and 21-May-2025, using an Anthology femoral component. From these, three hundred one (301) hips were later revised due to the following reasons: one hundred twelve (112) joints due to adverse soft tissue reaction to particle debris, thirty-seven (37) joints due to infection, thirty-three (33) joints due to dislocation/subluxation, thirty-two (32) joints due to other-unknown reasons, twenty-six (26) joints due to aseptic loosening of the stem, twenty (20) joints due to periprosthetic fracture of the stem, fifteen (15) joints due to malalignment of the socket, fourteen (14) joints due to pain, eight (8) joints due to malalignment of the stem, eight (8) joints due to periprosthetic fracture, seven (7) joints due to wear of the acetabular component, six (6) joints due to aseptic loosening of the socket, four (4) joints due to lysis of the socket, three (3) joints due to dissociation of the liner, three (3) joints due to lysis of the stem, three (3) joints due to periprosthetic fracture of the socket, two (2) joints due to implant fracture of the stem, two (2) joints due to leg length discrepancy, one (1) joint due to implant fracture of a ceramic component in the stem, one (1) joint due to incorrect sizing of the head, and one (1) joint due to incorrect sizing of the socket. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry data: Implantations conducted between 21-Aug-2006 and 21-May-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Anthology system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seven thousand and eighty-five (7085) procedures with Anthology stem were performed in United Kingdom between 21-Aug-2006 and 21-May-2025. ;;The cumulative revision rates for the Anthology stems are in line with the class as demonstrated by overlapping confidence across all years of follow-up, with the exception of the 10 year of follow up. The class was considered from the 21nd NJR Annual report 2024 all uncemented stems. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 0.93% (0.73%¿1.18%) vs 0.92% (0.89%¿0.94%) of the class. ;;-At 3rd postoperative year: 1.79% (1.5%¿2.13%) vs 1.63% (1.60%¿1.66%) of the class. ;;-At 5th postoperative year: 2.69% (2.32%¿3.12%) vs 2.30% (2.26%¿2.34%) of the class. ;;-At 10th postoperative year: 4.87% (4.32%¿5.48%) vs 4.24% (4.18%¿4.31%) of the class. ;;-At 15th postoperative year: 6.17% (5.4%¿7.05%) vs 6.60% (6.48%¿6.71%) of the class. ;;The most frequent reason for revision was adverse soft tissue reaction to particle debris (1,58%), followed by infection (0.52%) and dislocation/subluxation (0.47%). A potential reason for the elevated revision rate at 10 years of follow up could be due to the observed rate of revisions for reaction to metal debris which may have come from the selection of bearing materials and not related to the stem. It should be noted that, out of the 112 revisions listing ¿Adverse soft tissue reaction to particulate debris¿ as a reason for revision, 108 revisions involved a Metal-on-metal bearing which is no longer manufactured by Smith+Nephew.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend of the adverse event listed above have been identified. The reported adverse event relate to a known inherent procedural risk that is appropriately documented in our risk files. No individual investigation into the reported adverse event is deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Female,,5/21/2022,,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

IT WAS REPORTED THAT, IN THE NATIONAL JOINT REGISTRY (NJR) FROM THE UNITED KINGDOM, A TOTAL OF SIXTY-FIVE THOUSAND THREE HUNDRED AND TWENTY-NINE (65,329) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 24-APR-2008 AND 26-FEB-2025, USING AN R3 XLPE LINER. FROM THESE, EIGHT HUNDRED AND FIVE (805) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: DISLOCATION/SUBLUXATION (X241), INFECTION (X190), PERIPROSTHETIC FRACTURE (X222), ASEPTIC LOOSENING (X63), IMPLANT MALALIGNMENT (X62), PAIN (X27), OTHER-UNSPECIFIED REASONS (X39), ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (X17), WEAR OF ACETABULAR COMPONENT (X13), IMPLANT FRACTURE (X18), OSTEOLYSIS (X12), DISSOCIATION OF LINER (X5), UNEQUAL LIMB LENGTH (X5) AND IMPLANT MISMATCH (X6). NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 24-APR-2008 AND 26-FEB-2025 IN THE UNITED KINGDOM.

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY (THA): 1. PRIMARY THA PROCEDURES - R3 XLPE ACETABULAR LINER: A TOTAL OF SIXTY-FIVE THOUSAND THREE HUNDRED AND TWENTY-NINE (65,329) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 24-APR-2008 AND 26-FEB-2025, USING AN R3 XLPE LINER. FROM THESE, EIGHT HUNDRED AND FIVE (805) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: DISLOCATION/SUBLUXATION (241), INFECTION (190), PERIPROSTHETIC FRACTURE (222), ASEPTIC LOOSENING (63), IMPLANT MALALIGNMENT (62), PAIN (27), OTHER-UNSPECIFIED REASONS (39), ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (17), WEAR OF ACETABULAR COMPONENT (13), IMPLANT FRACTURE (18), OSTEOLYSIS (12), DISSOCIATION OF LINER (5), UNEQUAL LIMB LENGTH (5) AND IMPLANT MISMATCH (6). IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - CPCS FEMORAL STEM: A TOTAL OF SIXTEEN THOUSAND SIX HUNDRED AND SEVENTY-FOUR (16,674) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 6-MAY-2003 AND 31-MAR-2025, USING A CPCS STEM. FROM THESE, THREE HUNDRED AND EIGHTY-SIX (386) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY (20) HIPS DUE TO UNEXPLAINED PAIN, SEVENTY-FIVE (75) HIPS DUE TO DISLOCATION/SUBLUXATION, THIRTY-EIGHT (38) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, FIFTY-THREE (53) HIPS DUE TO INFECTION, THIRTY-SEVEN (37) HIPS DUE TO ASEPTIC LOOSENING OF THE STEM, NINETY-FOUR (94) HIPS DUE TO ASEPTIC LOOSENING OF THE CUP, ONE HUNDRED AND ONE (101) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, TEN (10) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE CUP, FOUR (4) HIPS DUE TO MALALIGNMENT OF THE STEM, EIGHTEEN (18) HIPS DUE TO MALALIGNMENT OF THE SOCKET, TWO (2) HIPS DUE TO LEG LENGTH DISCREPANCY, THIRTY-SEVEN (37) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, TWENTY (20) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, THIRTY-SIX (36) HIPS DUE TO LYSIS ASSOCIATED WITH THE CUP, ONE (1) HIP DUE TO IMPLANT FRACTURE OF THE CERAMIC HEAD, TWO (2) HIPS DUE TO IMPLANT FRACTURE OF THE CERAMIC LINER, TWO (2) HIPS DUE TO IMPLANT FRACTURE OF THE POLY LINER, FOUR (4) HIPS DUE TO DISSOCIATION OF THE LINER, AND TWELVE (12) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - REFLECTION XLPE ACETABULAR LINER: A TOTAL OF ONE THOUSAND NINE HUNDRED AND FOUR (1,904) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 10-FEB-2004 AND 22-MAR-2025, USING A REFLECTION XLPE LINER. FROM THESE, THIRTY (30) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, SIX (6) HIPS DUE TO INFECTION, SIX (6) HIPS DUE TO PAIN, SIX (6) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO MALALIGNMENT ASSOCIATED WITH THE SOCKET, TWO (2) HIPS DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO INCORRECT SIZING HEAD, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET AND ONE (1) HIP DUE TO OTHER/UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - REFLECTION XLPE ALL-POLY CUP: A TOTAL OF THREE THOUSAND THREE HUNDRED FIFTY-FOUR (3,354) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 13-SEP-2006 AND 18-APR-2025, USING A REFLECTION XLPE ALL-POLY CUP. FROM THESE, FIFTY-SIX (56) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TEN (10) HIPS DUE TO LOOSENING ¿ SOCKET, TWELVE (12) HIPS DUE TO DISLOCATION/SUBLUXATION, FOURTEEN (14) HIPS DUE TO INFECTION, ONE (1) HIP DUE TO UNEXPLAINED PAIN, FOUR (4) HIPS DUE TO MALALIGNMENT SOCKET, NINETEEN (19) HIPS DUE TO PERI-PROSTHETIC FRACTURE STEM, FOUR (4) HIPS DUE TO LOOSENING STEM, TWO (2) HIPS DUE TO MALALIGNMENT STEM, ONE (1) HIP DUE TO LYSIS ¿ STEM, ONE (1) HIP DUE TO LYSIS ¿ SOCKET, TWO (2) HIPS DUE TO PERI-PROSTHETIC FRACTURE SOCKET, THREE (3) HIPS DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS AND TWO (2) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - ANTHOLOGY FEMORAL STEM: A TOTAL OF SEVEN THOUSAND AND EIGHTY-FIVE (7085) HIPS UNDERWENT PRIMARY THA BETWEEN 21-AUG-2006 AND 21-MAY-2025, USING AN ANTHOLOGY FEMORAL COMPONENT. FROM THESE, THREE HUNDRED ONE (301) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED TWELVE (112) JOINTS DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, THIRTY-SEVEN (37) JOINTS DUE TO INFECTION, THIRTY-THREE (33) JOINTS DUE TO DISLOCATION/SUBLUXATION, THIRTY-TWO (32) JOINTS DUE TO OTHER-UNKNOWN REASONS, TWENTY-SIX (26) JOINTS DUE TO ASEPTIC LOOSENING OF THE STEM, TWENTY (20) JOINTS DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, FIFTEEN (15) JOINTS DUE TO MALALIGNMENT OF THE SOCKET, FOURTEEN (14) JOINTS DUE TO PAIN, EIGHT (8) JOINTS DUE TO MALALIGNMENT OF THE STEM, EIGHT (8) JOINTS DUE TO PERIPROSTHETIC FRACTURE, SEVEN (7) JOINTS DUE TO WEAR OF THE ACETABULAR COMPONENT, SIX (6) JOINTS DUE TO ASEPTIC LOOSENING OF THE SOCKET, FOUR (4) JOINTS DUE TO LYSIS OF THE SOCKET, THREE (3) JOINTS DUE TO DISSOCIATION OF THE LINER, THREE (3) JOINTS DUE TO LYSIS OF THE STEM, THREE (3) JOINTS DUE TO PERIPROSTHETIC FRACTURE OF THE SOCKET, TWO (2) JOINTS DUE TO IMPLANT FRACTURE OF THE STEM, TWO (2) JOINTS DUE TO LEG LENGTH DISCREPANCY, ONE (1) JOINT DUE TO IMPLANT FRACTURE OF A CERAMIC COMPONENT IN THE STEM, ONE (1) JOINT DUE TO INCORRECT SIZING OF THE HEAD, AND ONE (1) JOINT DUE TO INCORRECT SIZING OF THE SOCKET. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ACCORDING TO THE NJR MONTHLY DATA DOWNLOAD REVIEWED, AT LEAST ONE HUNDRED FIVE (105) REVISIONS INVOLVED THE USE OF R3 XLPE ACETABULAR LINERS AT PRIMARY, AS REFERENCED THROUGH THIS REPORT. ADDITIONALLY, ONE (1) REVISION INVOLVED THE USE OF A REFLECTION XLPE ACETABULAR LINER AT PRIMARY THA. SINCE THESE ONE HUNDRED SIX (106) REVISIONS ARE ALREADY COUNTED AS INDIVIDUAL EVENTS BASED ON THE NUMBER OF REVISIONS REPORTED FOR THE CORRESPONDING ACETABULAR LINERS, ONLY ONE HUNDRED FIVE (195) REVISIONS WILL BE ADDED TO THE TOTAL NUMBER OF EVENTS REPORTED IN THE ¿NUMBER OF EVENTS¿ FIELD IN SECTION H2 OF THE 3500A FORM. 2. REVISION THA PROCEDURES - R3 XLPE ACETABULAR LINER: A TOTAL OF EIGHT HUNDRED NINETY-EIGHT (898) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 10-SEP-2008 AND 07-FEB-2025, USING AN R3 XLPE ACETABULAR LINERS. FROM THESE, SEVENTY-EIGHT (78) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: DISLOCATION/SUBLUXATION (19), INFECTION (17), ASEPTIC LOOSENING (21), PERIPROSTHETIC FRACTURE (12), PAIN (10), ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (6), MALALIGNMENT OF IMPLANT (2), WEAR OF ACETABULAR COMPONENT (2), OTHER-UNKNOWN REASONS (2) AND OSTEOLYSIS ASSOCIATED WITH THE FEMORAL STEM (1). IT SHOULD BE NOTED THAT MORE THAN ONE REASON MAY BE LISTED FOR EACH REVISION SURGERY. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - REFLECTION XLPE ACETABULAR LINER: A TOTAL OF ONE HUNDRED AND NINETY-TWO (192) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 06-OCT-2004 AND 09-MAR-2015, USING A REFLECTION XLPE LINER. FROM THESE, TWENTY-SEVEN (27) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: EIGHT (8) HIPS DUE TO INFECTION, SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, FOUR (4) HIPS DUE TO PAIN, THREE (3) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, THREE (3) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THREE (3) HIPS DUE TO IMPLANT FRACTURE ASSOCIATED WITH THE FEMORAL STEM, TWO (2) HIPS DUE TO OTHER/UNKNOWN REASONS, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET AND ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION SURGERY. - SPECTRON FEMORAL STEM: A TOTAL OF EIGHTY-ONE (81) HIPS UNDERWENT THA REVISION PROCEDURES UPON WHICH A SPECTRON STEM WAS PLACED IN EXCHANGE OF THE PRIMARY FEMORAL COMPONENT BETWEEN 15-APR-2003 AND 22-FEB-2023. FROM THESE, FOUR (4) HIPS WERE RE-REVISED DUE TO THE FOLLOWING REASONS: ONE (1) OF THEM DUE TO ADVERSE SOFT TISSUE REACTION, TWO (2) DUE TO FEMORAL STEM ASEPTIC LOOSENING, AND TWO (2) DUE TO ACETABULAR SOCKET ASEPTIC LOOSENING. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION SURGERY. - REFLECTION XLPE ALL-POLY CUP: A TOTAL OF FIFTY (50) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 23-JAN-2007 AND 8-JAN-2025, USING A REFLECTION XLPE ALL-POLY CUP. FROM THESE, SIX (6) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO UNEXPLAINED PAIN, ONE (1) HIP DUE TO LYSIS ¿ STEM, ONE (1) HIP DUE TO LYSIS ¿ SOCKET, ONE (1) HIP DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS, ONE (1) HIP DUE TO PERI-PROSTHETIC FRACTURE ¿ STEM, TWO (2) HIPS DUE TO INFECTION AND ONE (1) HIP DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 1,472 REVISIONS AND 115 RE-REVISIONS (1,587 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE NATIONAL JOINT REGISTRY (NJR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY (THA): 1. PRIMARY THA PROCEDURES - R3 XLPE ACETABULAR LINER: A TOTAL OF SIXTY-FIVE THOUSAND THREE HUNDRED AND TWENTY-NINE (65,329) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 24-APR-2008 AND 26-FEB-2025, USING AN R3 XLPE LINER. FROM THESE, EIGHT HUNDRED AND FIVE (805) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: DISLOCATION/SUBLUXATION (241), INFECTION (190), PERIPROSTHETIC FRACTURE (222), ASEPTIC LOOSENING (63), IMPLANT MALALIGNMENT (62), PAIN (27), OTHER-UNSPECIFIED REASONS (39), ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (17), WEAR OF ACETABULAR COMPONENT (13), IMPLANT FRACTURE (18), OSTEOLYSIS (12), DISSOCIATION OF LINER (5), UNEQUAL LIMB LENGTH (5) AND IMPLANT MISMATCH (6). IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - CPCS FEMORAL STEM: A TOTAL OF SIXTEEN THOUSAND SIX HUNDRED AND SEVENTY-FOUR (16,674) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 6-MAY-2003 AND 31-MAR-2025, USING A CPCS STEM. FROM THESE, THREE HUNDRED AND EIGHTY-SIX (386) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY (20) HIPS DUE TO UNEXPLAINED PAIN, SEVENTY-FIVE (75) HIPS DUE TO DISLOCATION/SUBLUXATION, THIRTY-EIGHT (38) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, FIFTY-THREE (53) HIPS DUE TO INFECTION, THIRTY-SEVEN (37) HIPS DUE TO ASEPTIC LOOSENING OF THE STEM, NINETY-FOUR (94) HIPS DUE TO ASEPTIC LOOSENING OF THE CUP, ONE HUNDRED AND ONE (101) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, TEN (10) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE CUP, FOUR (4) HIPS DUE TO MALALIGNMENT OF THE STEM, EIGHTEEN (18) HIPS DUE TO MALALIGNMENT OF THE SOCKET, TWO (2) HIPS DUE TO LEG LENGTH DISCREPANCY, THIRTY-SEVEN (37) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, TWENTY (20) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, THIRTY-SIX (36) HIPS DUE TO LYSIS ASSOCIATED WITH THE CUP, ONE (1) HIP DUE TO IMPLANT FRACTURE OF THE CERAMIC HEAD, TWO (2) HIPS DUE TO IMPLANT FRACTURE OF THE CERAMIC LINER, TWO (2) HIPS DUE TO IMPLANT FRACTURE OF THE POLY LINER, FOUR (4) HIPS DUE TO DISSOCIATION OF THE LINER, AND TWELVE (12) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - REFLECTION XLPE ACETABULAR LINER: A TOTAL OF ONE THOUSAND NINE HUNDRED AND FOUR (1,904) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 01-JAN-2004 AND 27-MAY-2025, USING A REFLECTION XLPE LINER. FROM THESE, THIRTY (30) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, SIX (6) HIPS DUE TO INFECTION, SIX (6) HIPS DUE TO PAIN, SIX (6) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO MALALIGNMENT ASSOCIATED WITH THE SOCKET, TWO (2) HIPS DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO INCORRECT SIZING HEAD, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET AND ONE (1) HIP DUE TO OTHER/UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - REFLECTION XLPE ALL-POLY CUP: A TOTAL OF THREE THOUSAND THREE HUNDRED FIFTY-FOUR (3,354) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 13-SEP-2006 AND 18-APR-2025, USING A REFLECTION XLPE ALL-POLY CUP. FROM THESE, FIFTY-SIX (56) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TEN (10) HIPS DUE TO LOOSENING ¿ SOCKET, TWELVE (12) HIPS DUE TO DISLOCATION/SUBLUXATION, FOURTEEN (14) HIPS DUE TO INFECTION, ONE (1) HIP DUE TO UNEXPLAINED PAIN, FOUR (4) HIPS DUE TO MALALIGNMENT SOCKET, NINETEEN (19) HIPS DUE TO PERI-PROSTHETIC FRACTURE STEM, FOUR (4) HIPS DUE TO LOOSENING STEM, TWO (2) HIPS DUE TO MALALIGNMENT STEM, ONE (1) HIP DUE TO LYSIS ¿ STEM, ONE (1) HIP DUE TO LYSIS ¿ SOCKET, TWO (2) HIPS DUE TO PERI-PROSTHETIC FRACTURE SOCKET, THREE (3) HIPS DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS AND TWO (2) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - ANTHOLOGY FEMORAL STEM: A TOTAL OF SEVEN THOUSAND AND EIGHTY-FIVE (7085) HIPS UNDERWENT PRIMARY THA BETWEEN 21-AUG-2006 AND 21-MAY-2025, USING AN ANTHOLOGY FEMORAL COMPONENT. FROM THESE, THREE HUNDRED ONE (301) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED TWELVE (112) JOINTS DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, THIRTY-SEVEN (37) JOINTS DUE TO INFECTION, THIRTY-THREE (33) JOINTS DUE TO DISLOCATION/SUBLUXATION, THIRTY-TWO (32) JOINTS DUE TO OTHER-UNKNOWN REASONS, TWENTY-SIX (26) JOINTS DUE TO ASEPTIC LOOSENING OF THE STEM, TWENTY (20) JOINTS DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, FIFTEEN (15) JOINTS DUE TO MALALIGNMENT OF THE SOCKET, FOURTEEN (14) JOINTS DUE TO PAIN, EIGHT (8) JOINTS DUE TO MALALIGNMENT OF THE STEM, EIGHT (8) JOINTS DUE TO PERIPROSTHETIC FRACTURE, SEVEN (7) JOINTS DUE TO WEAR OF THE ACETABULAR COMPONENT, SIX (6) JOINTS DUE TO ASEPTIC LOOSENING OF THE SOCKET, FOUR (4) JOINTS DUE TO LYSIS OF THE SOCKET, THREE (3) JOINTS DUE TO DISSOCIATION OF THE LINER, THREE (3) JOINTS DUE TO LYSIS OF THE STEM, THREE (3) JOINTS DUE TO PERIPROSTHETIC FRACTURE OF THE SOCKET, TWO (2) JOINTS DUE TO IMPLANT FRACTURE OF THE STEM, TWO (2) JOINTS DUE TO LEG LENGTH DISCREPANCY, ONE (1) JOINT DUE TO IMPLANT FRACTURE OF A CERAMIC COMPONENT IN THE STEM, ONE (1) JOINT DUE TO INCORRECT SIZING OF THE HEAD, AND ONE (1) JOINT DUE TO INCORRECT SIZING OF THE SOCKET. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ACCORDING TO THE NJR MONTHLY DATA DOWNLOAD REVIEWED, AT LEAST ONE HUNDRED FIVE (105) REVISIONS INVOLVED THE USE OF R3 XLPE ACETABULAR LINERS AT PRIMARY, AS REFERENCED THROUGH THIS REPORT. ADDITIONALLY, ONE (1) REVISION INVOLVED THE USE OF A REFLECTION XLPE ACETABULAR LINER AT PRIMARY THA. SINCE THESE ONE HUNDRED SIX (106) REVISIONS ARE ALREADY COUNTED AS INDIVIDUAL EVENTS BASED ON THE NUMBER OF REVISIONS REPORTED FOR THE CORRESPONDING ACETABULAR LINERS, ONLY ONE HUNDRED FIVE (195) REVISIONS WILL BE ADDED TO THE TOTAL NUMBER OF EVENTS REPORTED IN THE ¿NUMBER OF EVENTS¿ FIELD IN SECTION H2 OF THE 3500A FORM. 2. REVISION THA PROCEDURES - R3 XLPE ACETABULAR LINER: A TOTAL OF EIGHT HUNDRED NINETY-EIGHT (898) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 10-SEP-2008 AND 07-FEB-2025, USING AN R3 XLPE ACETABULAR LINERS. FROM THESE, SEVENTY-EIGHT (78) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: DISLOCATION/SUBLUXATION (19), INFECTION (17), ASEPTIC LOOSENING (21), PERIPROSTHETIC FRACTURE (12), PAIN (10), ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (6), MALALIGNMENT OF IMPLANT (2), WEAR OF ACETABULAR COMPONENT (2), OTHER-UNKNOWN REASONS (2) AND OSTEOLYSIS ASSOCIATED WITH THE FEMORAL STEM (1). IT SHOULD BE NOTED THAT MORE THAN ONE REASON MAY BE LISTED FOR EACH REVISION SURGERY. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - REFLECTION XLPE ACETABULAR LINER: A TOTAL OF ONE HUNDRED AND NINETY-TWO (192) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 01-JAN-2004 AND 31-DEC-2015, USING A REFLECTION XLPE LINER. FROM THESE, TWENTY-SEVEN (27) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: EIGHT (8) HIPS DUE TO INFECTION, SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, FOUR (4) HIPS DUE TO PAIN, THREE (3) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, THREE (3) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THREE (3) HIPS DUE TO IMPLANT FRACTURE ASSOCIATED WITH THE FEMORAL STEM, TWO (2) HIPS DUE TO OTHER/UNKNOWN REASONS, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET AND ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION SURGERY. - SPECTRON FEMORAL STEM: A TOTAL OF EIGHTY-ONE (81) HIPS UNDERWENT THA REVISION PROCEDURES UPON WHICH A SPECTRON STEM WAS PLACED IN EXCHANGE OF THE PRIMARY FEMORAL COMPONENT BETWEEN 15-APR-2003 AND 22-FEB-2023. FROM THESE, FOUR (4) HIPS WERE RE-REVISED DUE TO THE FOLLOWING REASONS: ONE (1) OF THEM DUE TO ADVERSE SOFT TISSUE REACTION, TWO (2) DUE TO FEMORAL STEM ASEPTIC LOOSENING, AND TWO (2) DUE TO ACETABULAR SOCKET ASEPTIC LOOSENING. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION SURGERY. - REFLECTION XLPE ALL-POLY CUP: A TOTAL OF FIFTY (50) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 23-JAN-2007 AND 8-JAN-2025, USING A REFLECTION XLPE ALL-POLY CUP. FROM THESE, SIX (6) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO UNEXPLAINED PAIN, ONE (1) HIP DUE TO LYSIS ¿ STEM, ONE (1) HIP DUE TO LYSIS ¿ SOCKET, ONE (1) HIP DUE TO WEAR OF ACETABULAR COMPONENT, ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS, ONE (1) HIP DUE TO PERI-PROSTHETIC FRACTURE ¿ STEM, TWO (2) HIPS DUE TO INFECTION AND ONE (1) HIP DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 1,472 REVISIONS AND 115 RE-REVISIONS (1,587 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE NATIONAL JOINT REGISTRY (NJR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
329222	R3 XLPE INSERT	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED	JDI	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR	Unknown

Terms

Patient problem · 11

• Ambulation or Postural Difficulties
• Aseptic loosening
• Deformity/ Disfigurement
• Insufficient Information
• Joint Dislocation
• Local Reaction
• Osteolysis
• Pain
• Periprosthetic fracture
• Unequal Limb Length
• Unspecified Infection

Product problems · 7

• Adverse Event Without Identified Device or Use Problem
• Device Dislodged or Dislocated
• Fracture
• Improper or Incorrect Procedure or Method
• Loosening of Implant Not Related to Bone-Ingrowth
• Material Erosion
• Osseointegration Problem

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission